Beijing Fornurse Medical Equipment Co.,Ltd.

Manufacturer

🇨🇳 China·TÜV Rheinland LGA Products GmbH

Spatz FGIA Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Ophthalmic Slit Lamp Microscope LS-1A

Device

EU MDR · Eu Md Class 1 ·ChongQing Sunkingdom Medical Instrument Co. Ltd·On the market·2 countries

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

Spatz3 Adjustable Balloon System

Device

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·On the market·20 countries

DZ 2424698-1

Certificate

MDR QA·Beijing Fornurse Medical Equipment Co.,Ltd.·TÜV Rheinland LGA Products GmbH

CN23/00006997

Certificate

MDR QA·Shenzhen Zijian Biotechnology Co., Ltd·SGS Belgium NV

Spatz3 Adjustable Balloon System Insertion Kit

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Spatz FGIA Inc.·1 device

1000169818

Certificate

MDR QMS·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

170783435

Certificate

MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

170781760

Certificate

MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH

3901646CE01

Certificate

MDD Annex II (excluding section 4)·CathWorks Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

7406GB410210510A

Certificate

MDD Annex II (excluding section 4)·EyeYon Medical Ltd.·DNV MEDCERT GmbH·2 Basic UDI-DIs

542544 MDR2017P

Certificate

MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI

170781760

Certificate

MDR Technical Documentation·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·1 Basic UDI-DI

170769617

Certificate

MDD Annex II Section 4·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·5 Basic UDI-DIs

170771902

Certificate

MDD Annex II Section 4·Perflow Medical Ltd.·DQS Medizinprodukte GmbH·3 Basic UDI-DIs

26445

Certificate

MDD Annex II (excluding section 4)·Synergy Spine Solutions Inc.·GMED SAS·12 Basic UDI-DIs

2125546CE01

Certificate

MDD Annex II (excluding section 4)·IOPtima Ltd.·DEKRA Certification B.V.·1 Basic UDI-DI

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI