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24 0477 QR/NB

Certificate
MDR QMS·COMPEX, spol. s r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

2024-MDR/QS-060

Certificate
MDR QMS·Vortran Medical Technology 1 Inc.·3EC International a.s.

IT335406

Certificate
MDR QMS·Calopad AG·BUREAU VERITAS ITALIA S.P.A.

24 0263 QR/NB

Certificate
MDR QMS·KARDI AI Technologies s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

HZ 1566826-1

Certificate
MDR QMS·Wöhlk Contactlinsen GmbH·TÜV Rheinland LGA Products GmbH

24 0237 QR/NB

Certificate
MDR QMS·VINAMET CZ s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

24 0234 QR/NB

Certificate
MDR QMS·BATIST Medical Productions s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

24 0145 QR/NB

Certificate
MDR QMS·BIOSTER, a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

23 0517 QR/NB

Certificate
MDR QMS·GAMA GROUP a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

23 0493 QR/NB

Certificate
MDR QMS·Flídr medical s.r.o.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

ES23/00000028

Certificate
MDR QMS·A. J. Costa (Irmãos), Lda.·SGS Belgium NV

170775963

Certificate
MDR QMS·Haag-Streit AG·DQS Medizinprodukte GmbH

HZ 2320977-1

Certificate
MDR QMS·SP Medical A/S·TÜV Rheinland LGA Products GmbH

Elixir Medical Corporation

Manufacturer
🇺🇸 United States·2 Basic UDI-DIs·2 Devices·3 Importers·3EC International a.s., 3EC International a.s., and 3EC International a.s.

Fin-ceramica faenza spa

Manufacturer
🇮🇹 Italy·71 Basic UDI-DIs·110 Devices·ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', ISTITUTO SUPERIORE DI SANITA', and ISTITUTO SUPERIORE DI SANITA'

BIOSTER, a.s.

Manufacturer
🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Flídr medical s.r.o.

Manufacturer
🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

KARDI AI Technologies s.r.o.

Manufacturer
🇨🇿 Czechia·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390

Andon Health Co., Ltd.

Manufacturer
🇨🇳 China·8 Basic UDI-DIs·11 Devices·7 Importers·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH

WOLF-Medizintechnik GmbH

Manufacturer
🇩🇪 Germany·8 Basic UDI-DIs·8 Devices·3EC International a.s., 3EC International a.s., and 3EC International a.s.