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2195-MED-1935201

Certificate
MDD Annex II (excluding section 4)·MEDIKORS INC.·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

0068/QCO-DM/072-2017

Certificate
MDD Annex II (excluding section 4)·REMEDI Inc.·MTIC InterCert S.r.l.·5 Basic UDI-DIs

CE-MDD-0133/04/2021/01

Certificate
MDD Annex II (excluding section 4)·SPECLIPSE, Inc.·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi·2 Basic UDI-DIs

CE-MDD-0115/03/2021/01

Certificate
MDD Annex II (excluding section 4)·DEXLEVO INC.·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi·1 Basic UDI-DI

2017-MDD/QS-044/C, 2017-MDD/DE-045/C

Certificate
MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·35 Basic UDI-DIs

2023-MDR/QS-004

Certificate
MDR QMS·BNC KOREA, Inc.·3EC International a.s.

2195-MED-2012004

Certificate
MDD Annex II (excluding section 4)·REV-MED Inc.·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

G1 095551 0002

Certificate
MDD Annex II (excluding section 4)·REV-MED Inc.·TÜV SÜD Product Service GmbH·5 Basic UDI-DIs

2021-MDD/QS-023, 2021-MDD/DE-024

Certificate
MDD Annex II (excluding section 4)·BNC KOREA, Inc.·3EC International a.s.·25 Basic UDI-DIs

2195-MED-2108402

Certificate
MDD Annex V·C&V Tech Inc.·Szutest Uygunluk Değerlendirme A.Ş.·1 Basic UDI-DI

DAEJU MEDITECH ENGINEERING CO., LTD

Manufacturer
🇰🇷 South Korea·3 Basic UDI-DIs·3 Devices·MTIC InterCert S.r.l., MTIC InterCert S.r.l., and Kiwa Belgelendirme Hizmetleri A.Ş.

SCL Co., Ltd.

Manufacturer
🇰🇷 South Korea·55 Basic UDI-DIs·55 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

Ovistech Co., Ltd.

Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.

REV-MED Inc.

Manufacturer
🇰🇷 South Korea·6 Basic UDI-DIs·6 Devices·Szutest Uygunluk Değerlendirme A.Ş. and TÜV SÜD Product Service GmbH

BNC KOREA, Inc.

Manufacturer
🇰🇷 South Korea·60 Basic UDI-DIs·60 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Ibex medical systems co., Ltd.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·Szutest Uygunluk Değerlendirme A.Ş.

OXUS Co.,Ltd.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·MTIC InterCert S.r.l.

SJ Global Co., Ltd.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·3EC International a.s.

SPECLIPSE, Inc.

Manufacturer
🇰🇷 South Korea·2 Basic UDI-DIs·2 Devices·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi

DEXLEVO INC.

Manufacturer
🇰🇷 South Korea·1 Basic UDI-DI·1 Device·1 Importer·Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi