170030QS/NB

Certificate

MDD Annex II (excluding section 4)·Hangzhou Singclean Medical Products Co., Ltd.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·56 Basic UDI-DIs

170031CN/NB

Certificate

MDD Annex II Section 4·Hangzhou Singclean Medical Products Co., Ltd.·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390·56 Basic UDI-DIs

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

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

BY-GL-A-1,BY-GL-C-1,BY-GL-1(A),BY-GL-1(B),BY-GL-1(C),BY-GL-1(D),BY-GL-1(E), BY-GL-1(F),BY-GL-A-1(A),BY-GL-A-2,BY-GL-A-2(A),BY-GL-A-3,BY-GL-A-3(A),BY-GL-A-4,BY-GL-A-4(A),BY-GL-A-5,BY-GL-A-5(A),BY-GL-C-1(A),BY-GL-C-2,BY-GL-C-2(A),BY-GL-E-1

Basic UDI-DI

EU MDR · Eu Md Class 2a ·Ningbo Boya Medical Equipment Co., Ltd·4 devices

ZS 959-11 Bacfix Hook Holder Swizzle Stick

FDA registration

BANISTER TOOL, INC.·1 product·🇺🇸 United States

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

CamLoc Rail Clamp Low Profile (SWISS)

FDA registration

SCHUERCH CORPORATION·1 product·🇺🇸 United States