I-SMART DEVELOPMENTS LIMITED

Manufacturer

1 Basic UDI-DI·1 Device·1 Importer·Kiwa Dare B.V.

Calopad AG

Manufacturer

🇨🇭 Switzerland·BUREAU VERITAS ITALIA S.P.A.

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

BATIST Medical Productions s.r.o.

Manufacturer

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

COMPEX, spol. s r.o.

Manufacturer

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

VINAMET CZ s.r.o.

Manufacturer

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

Bonebridge AG

Manufacturer

🇨🇭 Switzerland·33 Basic UDI-DIs·185 Devices·TUV Rheinland Italia SRL

GAMA GROUP a.s.

Manufacturer

🇨🇿 Czechia·164 Basic UDI-DIs·200 Devices·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p., and ELEKTROTECHNICKÝ ZKUŠEBNÍ ÚSTAV, s.p.

20M00084CRT02

Certificate

MDR QMS·I-SMART DEVELOPMENTS LIMITED·Kiwa Dare B.V.

IT335406

Certificate

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

ITH 1343526 1

Certificate

MDR QMS·Med-Logix Srl·TUV Rheinland Italia SRL

013-00-00-MDR

Certificate

MDR QMS·LSM-MED S.r.l.·ITALCERT SRL

TNP/MDR/0012/4929/2023

Certificate

MDR QMS·MED-INSTAL Irena Ratajczak·TUV NORD Polska Sp. z o.o

ITH 2477191 1

Certificate

MDR QMS·Bonebridge AG·TUV Rheinland Italia SRL

HZ 2159866-1

Certificate

MDR QMS·Shandong Lee Med Technology Co., Ltd.·TÜV Rheinland LGA Products GmbH

TNP/MDR/0004/1127/2022

Certificate

MDR QMS·Zakład Techniki Medycznej "Tech-Med" Sp. z o.o.·TUV NORD Polska Sp. z o.o

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

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