41377776-04

Certificate

MDD Annex II (excluding section 4)·Spectra Medical Devices, LLC·INTERTEK SEMKO AB·4 Basic UDI-DIs

41314934-05

Certificate

MDD Annex II (excluding section 4)·NorthEast Monitoring, Inc.·INTERTEK SEMKO AB·3 Basic UDI-DIs

41343861

Certificate

MDD Annex II Section 4·Diagnosys LLC·INTERTEK SEMKO AB·1 Basic UDI-DI

41371473-04

Certificate

MDD Annex II (excluding section 4)·Shenzhen Kentro Medical Electronics CO.,LTD.·INTERTEK SEMKO AB·3 Basic UDI-DIs

41371473-04

Certificate

MDD Annex II (excluding section 4)·Shenzhen Kentro Medical Electronics CO.,LTD.·INTERTEK SEMKO AB·1 Basic UDI-DI

41377748-01

Certificate

MDD Annex II (excluding section 4)·American Surgical Company, LLC·INTERTEK SEMKO AB·1 Basic UDI-DI

41302127-00

Certificate

MDD Annex II (excluding section 4)·Eyenuk, Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI

41312638-02

Certificate

MDD Annex II (excluding section 4)·Nidek Medical Products Inc.·INTERTEK SEMKO AB·4 Basic UDI-DIs

41312638

Certificate

MDD Annex II (excluding section 4)·Nidek Medical Products Inc.·INTERTEK SEMKO AB·1 Basic UDI-DI

413106295

Certificate

MDD Annex II (excluding section 4)·Pressure Products Medical Device Manufacturing LLC.·INTERTEK SEMKO AB·1 Basic UDI-DI

413106296

Certificate

MDD Annex II Section 4·Pressure Products Medical Device Manufacturing LLC.·INTERTEK SEMKO AB·1 Basic UDI-DI

41377747-01

Certificate

MDD Annex II Section 4·American Surgical Company, LLC·INTERTEK SEMKO AB·2 Basic UDI-DIs

0106415

Certificate

MDD Annex III·Nanjing 3H Medical Products Co.,Ltd.·INTERTEK SEMKO AB·23 Basic UDI-DIs

413112298

Certificate

MDD Annex V·Biocomma Limited·INTERTEK SEMKO AB·1 Basic UDI-DI

41371470-03

Certificate

MDD Annex II (excluding section 4)·Shenzhen Fitfaith Technology Co., Ltd.·INTERTEK SEMKO AB·1 Basic UDI-DI

4371470-03

Certificate

MDD Annex II (excluding section 4)·Shenzhen Fitfaith Technology Co., Ltd.·INTERTEK SEMKO AB·1 Basic UDI-DI

41319383-02

Certificate

MDD Annex II Section 4·Medviso AB·INTERTEK SEMKO AB·3 Basic UDI-DIs

Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

FDA classification

FDA Class 1 ·Antigens, Ha (Including Ha Control), Influenza Virus A, B, C

Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

FDA classification

FDA Class 1 ·Antigens, Cf (Including Cf Control), Influenza Virus A, B, C

Directa AB

System producer

🇸🇪 Sweden