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

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

No. 11 0497 QS/NB

Certificate

IVDD Annex IV (excluding sections 4, 6)·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

No. 11 0498 CN/NB

Certificate

IVDD Annex IV Section 4·Abon Biopharm(Hangzhou) Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·2 Basic UDI-DIs

200234 QS/NB

Certificate

MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·4 Basic UDI-DIs

200234QS/NB

Certificate

MDD Annex II (excluding section 4)·AKAS MEDICAL EQUIPMENT·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

21 0212 QS/NB

Certificate

MDD Annex II (excluding section 4)·M.I.Tech Co., Ltd·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·12 Basic UDI-DIs

190004 QS/NB

Certificate

MDD Annex II (excluding section 4)·ICZ.HEA a.s.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

170222 QS/NB

Certificate

MDD Annex II (excluding section 4)·Spatz FGIA Inc.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·1 Basic UDI-DI

Urology

FDA registration

Sklar Corporation - Warehouse·23 products·🇺🇸 United States

Urology

FDA registration

Sklar Corporation·23 products·🇺🇸 United States

GIMMI GMBH

FDA registration

GIMMI GMBH·23 products·🇩🇪 Germany

ABALASE MEDICAL PRODUCTS LTD

Importer

18 Manufacturers

Plandent Oy

Importer

🇫🇮 Finland·43 Manufacturers

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

Notified body

🇨🇿 Czechia·16 Manufacturers·135 Basic UDI-DIs

Villin [CWWB1] 0.5mL

FDA registration

RICHARD-ALLAN SCIENTIFIC LLC·1 product·🇺🇸 United States