1434-MDD-149/2021

Certificate

MDD Annex II Section 4·RFBio Co., Ltd·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.·3 Basic UDI-DIs

Cutera, Inc.

Manufacturer

🇺🇸 United States·17 Basic UDI-DIs·21 Devices·2 Importers·TUV NORD Polska Sp. z o.o and TÜV NORD CERT GmbH

Fimet Oy

Manufacturer

🇫🇮 Finland·8 Basic UDI-DIs·15 Devices·SGS FIMKO OY and SGS FIMKO OY

Taewoong Medical Co., Ltd.

Manufacturer

🇰🇷 South Korea·236 Basic UDI-DIs·236 Devices·17 Importers·SGS Belgium NV and SGS Belgium NV

Radiant Innovation Inc.

Manufacturer

🇹🇼 Taiwan·19 Basic UDI-DIs·47 Devices·1 Importer·SGS Belgium NV and SGS Belgium NV

Shenzhen Hawk Medical Instrument Co., Ltd.

Manufacturer

🇨🇳 China·15 Basic UDI-DIs·23 Devices·4 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Lombard Medical Limited

Manufacturer

499 Basic UDI-DIs·499 Devices·4 Importers·DQS Medizinprodukte GmbH and DQS Medizinprodukte GmbH

Eyenuk, Inc.

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·1 Device·Intertek Medical Notified Body AB and INTERTEK SEMKO AB

CGI Suomi Oy

Manufacturer

🇫🇮 Finland·5 Basic UDI-DIs·5 Devices·Eurofins Electric & Electronics Finland Oy and Eurofins Electric & Electronics Finland Oy

FOTONA, proizvodnja optoelektronskih naprav d.o.o.

Manufacturer

🇸🇮 Slovenia·6 Basic UDI-DIs·8 Devices·3EC International a.s. and TÜV SÜD Product Service GmbH

Cavex Holland BV

Manufacturer

🇳🇱 Netherlands·33 Basic UDI-DIs·99 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Empatica S.r.L.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·TUV Rheinland Italia SRL and IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.

Tecnoclínic SA

Manufacturer

🇪🇸 Spain·25 Basic UDI-DIs·83 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

Ziehm Imaging GmbH

Manufacturer

🇩🇪 Germany·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

medentis medical GmbH

Manufacturer

🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

adeor medical AG

Manufacturer

🇩🇪 Germany·7 Basic UDI-DIs·7 Devices·SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ and SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ

Cerenion Ltd

Manufacturer

🇫🇮 Finland·2 Basic UDI-DIs·3 Devices·SGS FIMKO OY and SGS FIMKO OY

Asahi Kasei Medical Co., Ltd.

Manufacturer

🇯🇵 Japan·10 Basic UDI-DIs·27 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

Shimadzu Corporation

Manufacturer

🇯🇵 Japan·348 Basic UDI-DIs·361 Devices·2 Importers·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH

S.I.I.T. srl

Manufacturer

🇮🇹 Italy·3 Basic UDI-DIs·3 Devices·ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL