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

ICZ.HEA a.s.

Manufacturer

🇨🇿 Czechia·1 Basic UDI-DI·1 Device·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

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

CMC Medical Devices & Drugs SL

Authorized representative

🇪🇸 Spain·698 Manufacturers·11260 Devices

Abon Biopharm(Hangzhou) Co., Ltd

Manufacturer

🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS

SUNGO Europe B.V.

Authorized representative

🇳🇱 Netherlands·1571 Manufacturers·20390 Devices

Hangzhou Singclean Medical Products Co., Ltd.

Manufacturer

🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.

M.I.Tech Co., Ltd

Manufacturer

🇰🇷 South Korea·809 Basic UDI-DIs·809 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH

13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XS

FDA registration

CORFLEX·1 product·🇺🇸 United States

13" ANT CL KNEE WRAP OP POP W/HINGE 3/16" XS

FDA registration

Corflex Caribe·1 product·🇩🇴 Dominican Republic

Securitas Healthcare LLC

FDA registration

CYIENT DLM LIMITED·1 product·🇮🇳 India

Securitas Healthcare LLC

FDA registration

CYIENT DLM LIMITED·1 product·🇮🇳 India

BROWNE MODEL CF-1 AND CF-1G

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

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.

HCV ANTIBODY -RT & POC

Device

EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market

HBSAG - RT & POC

Device

EU IVDD · Eu Ivd Annex 2 List A ·Abon Biopharm(Hangzhou) Co., Ltd·On the market