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Abon Biopharm(Hangzhou) Co., Ltd

Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

SB-KAWASUMI LABORATORIES, INC.

Manufacturer
🇯🇵 Japan·408 Basic UDI-DIs·426 Devices·2 Importers·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

Soteria Biotech Co., Ltd.

Manufacturer
🇹🇼 Taiwan·1 Basic UDI-DI·1 Device·TÜV SÜD Product Service GmbH

GC Medical Science Corporation

Manufacturer
🇰🇷 South Korea·11 Basic UDI-DIs·11 Devices·TÜV SÜD Product Service GmbH

NanoEntek, Inc.

Manufacturer
🇰🇷 South Korea·57 Basic UDI-DIs·68 Devices·TÜV SÜD Product Service GmbH

Atlas Link Technology Co., Ltd.

Manufacturer
🇨🇳 China·8 Basic UDI-DIs·8 Devices·1 Importer·TÜV SÜD Product Service GmbH

G1 102623 0002

Certificate
MDD Annex II (excluding section 4)·Soteria Biotech Co., Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

G1 016328 0144

Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

G1 016328 0144

Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·401 Basic UDI-DIs

G1 016328 0145

Certificate
MDD Annex II (excluding section 4)·SB-KAWASUMI LABORATORIES, INC.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

V1 064393 0011

Certificate
IVDD Annex IV (excluding sections 4, 6)·NanoEntek, Inc.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

No. V1 058228 0009

Certificate
IVDD Annex IV (excluding sections 4, 6)·Abon Biopharm(Hangzhou) Co., Ltd·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

V1 057995 0009

Certificate
IVDD Annex IV (excluding sections 4, 6)·Atlas Link Technology Co., Ltd.·TÜV SÜD Product Service GmbH·8 Basic UDI-DIs

V1 049753 0022

Certificate
IVDD Annex IV (excluding sections 4, 6)·GC Medical Science Corporation·TÜV SÜD Product Service GmbH·2 Basic UDI-DIs

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

ARTERIOVENOUS FISTULA NEEDLES

Device
EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries