RESOLUÇÃO RE Nº 2.540, DE 22 DE AGOSTO DE

UF II PACK-SED

RESOLUÇÃO RE Nº 2.540, DE 22 DE AGOSTO DE

O Diretor da Diretoria Colegiada da Agência Nacional de Vigilância Sanitária, no uso das atribuições que lhe conferem o De- creto de nomeação de 6 de julho de 2005 do Presidente da República, o inciso VIII do art. 15 e o inciso III do art. 49 e o inciso I § 1º do art. 55 do Regimento Interno aprovado nos termos do Anexo I da Portaria n.º 354 da ANVISA, de 11 de agosto de 2006, republicada no DOU de 21 de agosto de 2006, e a Portaria nº 524 da ANVISA, de 11 de Julho de 2007,

considerando o art. 12 e o art. 25 da Lei n.º 6.360, de 23 de setembro de 1976, bem como o inciso IX, do art. 7º da Lei n.º 9.782, de 26 de janeiro de 1999, resolve:

Art. 1º Conceder o Registro, o Cadastramento, a Revali- dação, a Alteração, a Inclusão, a Retificação, o Cancelamento e o Desarquivamento de Processo, dos Produtos para a Saúde, na con- formidade da relação anexa.

Art. 2º Esta Resolução entra em vigor na data de sua pu- blicação.

CLÁUDIO MAIEROVITCH PESSANHA HENRIQUES

ANEXO NOME DA EMPRESA AUTORIZAÇÃO NOME TÉCNICO NUMERO DO PROCESSO NOME COMERCIAL LOCAL DE FABRICAÇÃO MODELO(s) DO PRODUTO CLASSE REGISTRO PETIÇÃO(ÕES) ____________________________________________________ ABBOTT LABORATÓRIOS DO BRASIL LTDA 8.01465-0 Suturador Vascular 25351.070642/2006-11

STARCLOSE VASCULAR CLOSURE SYSTEM

FABRICANTE : PERCLOSE INC. (ABBOTT VASCULAR DEVI- CES) - ESTADOS UNIDOS

DISTRIBUIDOR : ABBOTT VASCULAR DEVICES HOLLAND B V - PAÍSES BAIXOS

CLASSE : IV 80146501353

8045 - Alteração das Instruções de Uso / Manual do Usuário/RE- LATÓRIO TÉCNICO e/ou Rotulagem de MATERIAL DE USO MÉ- DICO Nacional ou Importado, de acordo com a legislação vigente ---

ACCUMED PRODUTOS MÉDICO HOSPITALARES LTDA

8.02753-1

Lancetas 25351.006497/2007-03

LANCETA PARA LANCETADOR PREMIUM

FABRICANTE : Wuxi Xinda Medical Device Co, Ltd - CHINA DISTRIBUIDOR : Wuxi Xinda Medical Device Co, Ltd - CHINA LANCETA PARA LANCETADOR PREMIUM

COMERCIALIZAÇÃO E REPRODUÇÃO PROIBIDAS

LSA1B022 + LSPWABS LSA1-B022;LABScreen® Singles - B42

(B*4201), Bw6 - includes LSA1B023 + LSPWABS LSA1-

B023;LABScreen® Singles - B44 (B*4402), Bw4 - includes LSA1B024 + LSPWABS LSA1-B024;LABScreen® Singles - B44

(B*4403), Bw4 - includes LSA1B025 + LSPWABS LSA1-

B025;LABScreen® Singles - B45 (B*4501), Bw6 - includes LSA1B026 + LSPWABS LSA1-B026;LABScreen® Singles - B46

(B*4601), Bw6 - includes LSA1B027 + LSPWABS LSA1-

B027;LABScreen® Singles - B47 (B*4701), Bw4 - includes LSA1B028 + LSPWABS LSA1-B028;LABScreen® Singles - B48

(B*4801), Bw6 - includes LSA1B029 + LSPWABS LSA1-

B029;LABScreen® Singles - B49 (B*4901), Bw4 - includes LSA1B030 + LSPWABS LSA1-B030;LABScreen® Singles - B50

(B*5001), Bw6 - includes LSA1B031 + LSPWABS LSA1-

B031;LABScreen® Singles - B51 (B*5101), Bw4 - includes LSA1B032 + LSPWABS LSA1-B032;LABScreen® Singles - B51

(B*5102), Bw4 - includes LSA1B033 + LSPWABS LSA1-

B033;LABScreen® Singles - B52 (B*5201), Bw4 - includes LSA1B034 + LSPWABS LSA1-B034;LABScreen® Singles - B53

(B*5301), Bw4 - includes LSA1B035 + LSPWABS LSA1-

B035;LABScreen® Singles - B54 (B*5401), Bw6 - includes LSA1B036 + LSPWABS LSA1-B036;LABScreen® Singles - B55

(B*5501), Bw6 - includes LSA1B037 + LSPWABS LSA1-

B037;LABScreen® Singles - B55 (B*5502), Bw6 - includes LSA1B051 + LSPWABS LSA1-B051;LABScreen® Singles - B56

(B*5601), Bw6 - includes LSA1B038 + LSPWABS LSA1-

B038;LABScreen® Singles - B57 (B*5701), Bw4 - includes LSA1B039 + LSPWABS LSA1-B039;LABScreen® Singles - B57

(B*5703), Bw4 - includes LSA1B040 + LSPWABS LSA1-

B040;LABScreen® Singles - B58 (B*5801), Bw4 - includes LSA1B041 + LSPWABS LSA1-B041;LABScreen® Singles - B59

(B*5901), Bw4 - includes LSA1B042 + LSPWABS LSA1-

B042;LABScreen® Singles - B60 (B*4001), Bw6 - includes LSA1B020 + LSPWABS LSA1-B020;LABScreen® Singles - B61

(B*4002), Bw6 - includes LSA1B021 + LSPWABS LSA1-

B021;LABScreen® Singles - B61 (B*4006), Bw6 - includes LSA1B050 + LSPWABS LSA1-B050;LABScreen® Singles - B62

(B*1501), Bw6 - includes LSA1B006 + LSPWABS LSA1-

B006;LABScreen® Singles - B63 (B*1516), Bw4 - includes LSA1B012 + LSPWABS LSA1-B012;LABScreen® Singles - B64

(B*1401), Bw6 - includes LSA1B004 + LSPWABS LSA1-

B004;LABScreen® Singles - B65 (B*1402), Bw6 - includes LSA1B005 + LSPWABS LSA1-B005;LABScreen® Singles - B67

(B*6701), Bw6 - includes LSA1B043 + LSPWABS LSA1-

B043;LABScreen® Singles - B71 (B*1510), Bw6 - includes LSA1B009 + LSPWABS LSA1-B009;LABScreen® Singles - B72

(B*1503), Bw6 - includes LSA1B008 + LSPWABS LSA1-

B008;LABScreen® Singles - B73 (B*7301), Bw6 - includes LSA1B044 + LSPWABS LSA1-B044;LABScreen® Singles - B75

(B*1502), Bw6 - includes LSA1B007 + LSPWABS LSA1-

B007;LABScreen® Singles - B75 (B*1511), Bw6 - includes LSA1B049 + LSPWABS LSA1-B049;LABScreen® Singles - B76

(B*1512), Bw6 - includes LSA1B010 + LSPWABS LSA1-

B010;LABScreen® Singles - B77 (B*1513), Bw4 - includes LSA1B011 + LSPWABS LSA1-B011;LABScreen® Singles - B78

(B*7801), Bw6 - includes LSA1B045 + LSPWABS LSA1-

B045;LABScreen® Singles - B81 (B*8101), Bw6 - includes LSA1B046 + LSPWABS LSA1-B046;LABScreen® Singles - B82 (B*8201), Bw6 - includes LSA1B047 + LSPWABS LSA1-B047;Soro de Controle Negativo para Uso com Kit LabScreen - LS-NC - 1 x 400uL;Teste LabScreen de Detecção de Anticorpos de Antígenos Únicos HLA de Classe I - Grupo 3 - LS1A03;Teste LabScreen de Detecção de Anticorpos de Antígenos Únicos HLA de Classe II - Grupo 1 - LS2A01;Teste LabScreen de Detecção de Anticorpos MI- CA de Antígenos Únicos e suas Especificidades - LSMI- CA001;LABScreen® Singles - Cw1 (Cw*0102) - includes LSA1- C001 + LSPWABS LSA1-C001;LABScreen® Singles (DPB1*0101) - includes LSA2-P001 + LSPWABS LSA2-P001;LABScreen® Sin- gles (DPB1*0201) - includes LSA2-P002 + LSPWABS LSA2- P002;LABScreen® Singles (DPB1*0301) - includes LSA2-P003 + LSPWABS LSA2-P003;LABScreen® Singles (DPB1*0401) - includes LSA2-P004 + LSPWABS LSA2-P004;LABScreen® Singles

(DPB1*0402) - includes LSA2-P005 + LSPWABS LSA2-

P005;LABScreen® Singles (DPB1*0501) - includes LSA2-P006 + LSPWABS LSA2-P006;LABScreen® Singles (DPB1*0901) - includes LSA2-P007 + LSPWABS LSA2-P007;LABScreen® Singles

(DPB1*1001) - includes LSA2-P008 + LSPWABS LSA2-

P008;LABScreen® Singles (DPB1*1101) - includes LSA2-P009 + LSPWABS LSA2-P009;LABScreen® Singles - Cw10 (Cw*0302) - includes LSA1-C003 + LSPWABS LSA1-C003;LABScreen® Singles - Cw9 (Cw*0303) - includes LSA1-C004 + LSPWABS LSA1- C004;LABScreen® Singles - Cw10 (Cw*0304) - includes LSA1- C005 + LSPWABS LSA1-C005;LABScreen® Singles - Cw4 (Cw*0401) - includes LSA1-C006 + LSPWABS LSA1-C006;LABS- creen® Singles - Cw5 (Cw*0501) - includes LSA1-C007 + LSPWABS LSA1-C007;LABScreen® Singles - Cw6 (Cw*0602) - includes LSA1-C008 + LSPWABS LSA1-C008;LABScreen® Singles - Cw7 (Cw*0702) - includes LSA1-C009 + LSPWABS LSA1- C009;LABScreen® Singles - Cw8 (Cw*0801) - includes LSA1-C010 + LSPWABS LSA1-C010;LABScreen® Singles - Cw12 (Cw*1203) - includes LSA1-C011 + LSPWABS LSA1-C011;LABScreen® Sin- gles - Cw14 (Cw*1402) - includes LSA1-C012 + LSPWABS LSA1- C012;LABScreen® Singles - Cw15 (Cw*1502) - includes LSA1- C013 + LSPWABS LSA1-C013;LABScreen® Singles - Cw16 (Cw*1601) - includes LSA1-C014 + LSPWABS LSA1-C014;LABS- creen® Singles - Cw17 (Cw*1701) - includes LSA1-C015 + LSPWABS LSA1-C015;LABScreen® Singles - Cw18 (Cw*1802) - includes LSA1-C016 + LSPWABS LSA1-C016;LABScreen® Singles - Cw2 (Cw*0202) - includes LSA1-C002 + LSPWABS LSA1- C002;LABScreen® Singles (DPB1*1301) - includes LSA2-P010 +

LSPWABS LSA2-P010;LABScreen® Singles (DQB1*0201,

DQA1*0201) - includes LSA2-Q001 + LSPWABS LSA2-

Q001;LABScreen® Singles (DQB1*0202, DQA1*0201) - includes LSA2-Q004 + LSPWABS LSA2-Q004;LABScreen® Singles (DQB1*0401, DQA1*0201) - includes LSA2-Q005 + LSPWABS LSA2-Q005;LABScreen® Singles (DQB1*0402, DQA1*0201) - includes LSA2-Q006 + LSPWABS LSA2-Q006;LABScreen® Singles (DQB1*0501, DQA1*0101) - includes LSA2-Q008 + LSPWABS LSA2-Q008;LABScreen® Singles (DQB1*0602, DQA1*0102) - includes LSA2-Q011 + LSPWABS LSA2-Q011;LABScreen® Singles (DQB1*0301, DQA1*0301) - includes LSA2-Q012 + LSPWABS LSA2-Q012;LABScreen® Singles (DQB1*0301, DQA1*0601) - includes LSA2-Q014 + LSPWABS LSA2-Q014;LABScreen® Singles (DQB1*0302, DQA1*0101) - includes LSA2-Q015 + LSPWABS LSA2-Q015;LABScreen® Singles (DQB1*0303, DQA1*0201) - includes LSA2-Q018 + LSPWABS LSA2-Q018;LABScreen® Singles

(DRB1*0101) - includes LSA2-R003 + LSPWABS LSA2-

R003;LABScreen® Singles (DRB1*0401) - includes LSA2-R008 + LSPWABS LSA2-R008;LABScreen® Singles (DRB1*0405) - includes LSA2-R010 + LSPWABS LSA2-R010;LABScreen® Singles

(DRB1*0801) - includes LSA2-R012 + LSPWABS LSA2-

R012;LABScreen® Singles (DRB1*1101) - includes LSA2-R015 + LSPWABS LSA2-R015;LABScreen® Singles (DRB1*1301) - includes LSA2-R017 + LSPWABS LSA2-R017;LABScreen® Singles

(DRB1*1401) - includes LSA2-R019 + LSPWABS LSA2-

R019;LABScreen® Singles (DRB1*1502) - includes LSA2-R021 + LSPWABS LSA2-R021;LABScreen® Singles (DRB1*1601) - includes LSA2-R022 + LSPWABS LSA2-R022;LABScreen® Singles

(DRB5*0101) - includes LSA2-R027 + LSPWABS LSA2-

R027;LABScreen® Singles (DRB5*0202) - includes LSA2-R028 + LSPWABS LSA2-R028;LABScreen® Singles (DPB1*1701) - includes LSA2-P012 + LSPWABS LSA2-P012;LABScreen® Singles (DQB1*0301, DQA1*0303) - includes LSA2-Q013 + LSPWABS LSA2-Q013;LABScreen® Singles (DRB1*0103) - includes LSA2- R005 + LSPWABS LSA2-R005;LABScreen® Singles (DRB1*0404) - includes LSA2-R009 + LSPWABS LSA2-R009;LABScreen® Sin- gles (DRB1*0701) - includes LSA2-R011 + LSPWABS LSA2- R011;LABScreen® Singles (DRB1*1201) - includes LSA2-R016 + LSPWABS LSA2-R016;LABScreen® Singles (DRB1*1303) - includes LSA2-R018 + LSPWABS LSA2-R018;LABScreen® Singles

(DRB4*0101) - includes LSA2-R025 + LSPWABS LSA2-

R025;LABScreen® Singles (DPB1*1401) - includes LSA2-P011 +

LSPWABS LSA2-P011;LABScreen® Singles (DQB1*0201,

DQA1*0301) - includes LSA2-Q002 + LSPWABS LSA2-

Q002;LABScreen® Singles (DQB1*0201, DQA1*0501) - includes LSA2-Q003 + LSPWABS LSA2-Q003;LABScreen® Singles

(DRB1*1501) - includes LSA2-R020 + LSPWABS LSA2-

R020;LABScreen® Singles (DPB1*1901) - includes LSA2-P013 +

LSPWABS LSA2-P013;LABScreen® Singles (DQB1*0402

,DQA1*0401) - includes LSA2-Q007 + LSPWABS LSA2-

Q007;LABScreen® Singles (DQB1*0502, DQA1*0102) - includes LSA2-Q009 + LSPWABS LSA2-Q009;LABScreen® Singles (DQB1*0601, DQA1*0103) - includes LSA2-Q010 + LSPWABS LSA2-Q010;LABScreen® Singles (DQB1*0302, DQA1*0301) - includes LSA2-Q016 + LSPWABS LSA2-Q016;LABScreen® Singles (DQB1*0303, DQA1*0301) - includes LSA2-Q017 + LSPWABS LSA2-Q017;LABScreen® Singles (DRB1*0102) - includes LSA2- R004 + LSPWABS LSA2-R004;LABScreen® Singles (DRB1*0301) - includes LSA2-R006 + LSPWABS LSA2-R006;LABScreen® Sin- gles (DRB1*0302) - includes LSA2-R007 + LSPWABS LSA2- R007;LABScreen® Singles (DRB1*0901) - includes LSA2-R013 + LSPWABS LSA2-R013;LABScreen® Singles (DRB1*1001) - includes LSA2-R014 + LSPWABS LSA2-R014;LABScreen® Singles

(DRB3*0101) - includes LSA2-R023 + LSPWABS LSA2-

R023;LABScreen® Singles (DRB3*0202) - includes LSA2-R024 + LSPWABS LSA2-R024;LABScreen® Singles (DRB4*0103) - includes LSA2-R026 + LSPWABS LSA2-R026

CLASSE : III 80298490004

8320 - ALTERAÇÃO de Registro de FAMÍLIA de Produtos para Diagnóstico de uso in vitro por inclusão de produto

--- BIOTECHNOLOGY ORTOPEDIA IMPORTAÇÃO E EXPORTA- ÇÀO LTDA 1.02311-6

Proteses de Quadril 25351.007552/02-99 CABECA INTERCAMBIAVEL

FABRICANTE : BIOTECHNOLOGY ORTOPEDIA IMPORTAÇÃO E EXPORTAÇÀO LTDA - BRASIL

DISTRIBUIDOR : BIOTECHNOLOGY ORTOPEDIA IMPORTA- ÇÃO E EXPORTAÇÀO LTDA - BRASIL

Cabeça Femoral Intercambiável Cone 12/13: 07.04.02.22000;

07.04.02.22005; 07.04.02.22010; 07.04.02.22015; 07.04.02.26000; 07.04.02.26005; 07.04.02.26010; 07.04.02.26015; 07.04.02.28000; 07.04.02.28005; 07.04.02.28010; 07.04.02.28015; 07.04.02.32000; 07.04.02.32005; 07.04.02.32010; 07.04.02.32015.

Cabeça Femoral Intercambiável Cone 12/14: 07.04.03.22000;

07.04.03.22005; 07.04.03.22010; 07.04.03.22015; 07.04.03.26000; 07.04.03.26005; 07.04.03.26010; 07.04.03.26015; 07.04.03.28000; 07.04.03.28005; 07.04.03.28010; 07.04.03.28015; 07.04.03.32000; 07.04.03.32005; 07.04.03.32010; 07.04.03.32015.

Cabeça Umeral: 07.04.05.14038; 07.04.05.16040; 07.04.05.20044.

Cabeça Femoral Intercambiável Cone 10/11: 07.04.01.22000;

07.04.01.22005; 07.04.01.22010; 07.04.01.22015; 07.04.01.26000; 07.04.01.26005; 07.04.01.26010; 07.04.01.26015; 07.04.01.28000; 07.04.01.28005; 07.04.01.28010; 07.04.01.28015; 07.04.01.32000; 07.04.01.32005; 07.04.01.32010; 07.04.01.32015. Cabeça Monopolar: 07.04.04.01038; 07.04.04.01039; 07.04.04.01040; 07.04.04.01041; 07.04.04.01042; 07.04.04.01043; 07.04.04.01044; 07.04.04.01045; 07.04.04.01046; 07.04.04.01047; 07.04.04.01048; 07.04.04.01049; 07.04.04.01050; 07.04.04.01051; 07.04.04.01052; 07.04.04.01053; 07.04.04.01054. CLASSE : III 10231160057

8032 - Revalidação de Registro de FAMÍLIA de Material de Uso Médico

8045 - Alteração das Instruções de Uso / Manual do Usuário/RE- LATÓRIO TÉCNICO e/ou Rotulagem de MATERIAL DE USO MÉ- DICO Nacional ou Importado, de acordo com a legislação vigente --- BOITUVA INDÚSTRIA E COMÉRCIO LTDA 8.02115-7

ESTEIRA ERGOMÉTRICA UTILIZADA PARA DIAGNÓSTICO MÉDICO 25351.155125/2007-00

GAIT TRAINER

FABRICANTE : BIODEX MEDICAL SYSTEMS, INC. - ESTADOS UNIDOS

DISTRIBUIDOR : BIODEX MEDICAL SYSTEMS, INC. - ESTA- DOS UNIDOS

GAIT TRAINER CLASSE : I 80211570003

8049 - Registro de Equipamento IMPORTADO, de Médio e Pequeno Porte

--- CAPRICORN TECHNOLOGIES DO BRASIL LTDA 1.03876-5 Medidor de Glicose 25351.187293/2007-56

Glucocare

FABRICANTE : General Biological Corp. - CHINA DISTRIBUIDOR : General Biological Corp. - CHINA CLASSE : I 10387650091

8049 - Registro de Equipamento IMPORTADO, de Médio e Pequeno Porte

--- CARBOGEL INDÚSTRIA E COMÉRCIO LTDA. 8.00059-1 Gel Para Eletrodo 25000.002534/00-84

MEIO DE CONTATO PARA TRANSMISSAO ULTRASSONICA- CARBOGEL

FABRICANTE : CARBOGEL INDÚSTRIA E COMÉRCIO LTDA. - BRASIL

FRASCOS PLÁSTICOS COM: 100G; 250G; 300G; 400G. GAR- RAFAS PLÁSTICAS COM: 1KG; 2KG. BUJÃO COM: 5KG. BAL- DE COM: 20KG. BOMBONAS COM: 40KG; 50KG; 60KG; 70KG; 80KG; 90KG; 100KG.

CLASSE : I 80005910004

8042 - Alteração da Apresentação Comercial (componentes) de MA- TERIAL DE USO MÉDICO Importado ou Nacional

--- CARDINAL HEALTH BRASIL 402 LTDA 1.00175-4 Agulhas 25351.253547/2004-99

AGULHA PARA BIOPSIA DE MEDULA OSSEA JAMSHIDI FABRICANTE : CARDINAL HEALTH - ESTADOS UNIDOS DISTRIBUIDOR : CARDINAL HEALTH - ESTADOS UNIDOS D J 2 0 1 3 X ; D J 3 5 1 3 X ; D J 4 0 11 X ; D J 6 0 11 X ; D J 4 0 0 8 X ; C J 4 0 11 X ; C J 4 0 0 8 X ; E J 3 5 1 3 ; E J 4 0 11 ; E J 4 0 0 8 ;

CLASSE : I 10017540024

8044 - Alteração do Fabricante/Fornecedor de MATERIAL DE USO MÉDICO Importado ou Nacional

--- COM. IMP. DE PROD. MED. HOSP. PROSINTESE LTDA 1.03703- 7

Aplicador e Misturador de Cimento Ortopedico 25351.008035/02-82 OPTIVAC KIT DE CIMENTACAO

FABRICANTE : BIOMET CEMENTING TECHNOLOGIES AB - SUECIA

DISTRIBUIDOR : BIOMET CEMENTING TECHNOLOGIES AB - SUECIA

OPTIVAC L (código 4152); OPTIVAC S (código 4161); OPTIVAC M (código 4160); OPTIVAC HIP SET (código 4150);

CLASSE : I 10370370029

--- DPC MEDLAB PRODUTOS MEDICO HOSPITALARES LTDA 1.00717-7

Deteccao/Quantificacao de Marcadores Tumorais 25000.034611/96- 25

PSA LIVRE IMMULITE

FABRICANTE : EURO DPC - INGLATERRA Kit para 100 testes ou 500 testes

CLASSE : B 10071770050

8009 - ALTERAÇÃO da Apresentação Comercial do Registro/Ca- dastro de Produtos para Diagnóstico de uso in vitro

8014 - REVALIDAÇÃO DE REGISTRO de Produtos para Diag- nóstico de uso in vitro

COMERCIALIZAÇÃO E REPRODUÇÃO PROIBIDAS

Tampoes,Solucoes Eletrol.Diluentes/Demais Solucoes 25351.166770/2007-40

DILUENTE DE AMOSTRA DE ESTRADIOL IMMULITE FABRICANTE : DIAGNOSTIC PRODUCTS CORPORATION - ES- TADOS UNIDOS

01 x 25 ml

CLASSE : A 10071770557

8002 - REGISTRO de Produtos para Diagnóstico de uso in vitro, I M P O RTA D O

--- DPO-IMP. EXP. E COM. DE PROD. ODONTOLÓGICOS LTDA 1.03364-6

Condicionadores Acidos 25351.040601/2007-81

FAMÍLIA DE CONDICIONADORES ÁCIDOS COM BAC FABRICANTE : BISCO INC - ESTADOS UNIDOS DISTRIBUIDOR : BISCO INC - ESTADOS UNIDOS

ETCH 37 COM BAC, UNIETCH COM BAC, UNIETCH EZ DOSE

No documento COMERCIALIZAÇÃO E REPRODUÇÃO PROIBIDAS (páginas 34-36)