NIOX MINO

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

Fc, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fc, Fitc, Antigen, Antiserum, Control

Fc, Rhodamine, Antigen, Antiserum, Control

FDA classification

FDA Class 1 ·Fc, Rhodamine, Antigen, Antiserum, Control

Donawa Lifescience Consulting Srl

Authorized representative

🇮🇹 Italy·31 Manufacturers·15 Devices

0425-MED-00350400

Certificate

MDD Annex II (excluding section 4)·Dima Italia S.r.l.·ICIM S.P.A.·8 Basic UDI-DIs

0425-MED-004425-00

Certificate

MDD Annex V·USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l.·ICIM S.P.A.·2 Basic UDI-DIs

MED-003504-00

Certificate

MDD Annex II (excluding section 4)·Dima Italia S.r.l.·ICIM S.P.A.·1 Basic UDI-DI

0425-MED-3504-00

Certificate

MDD Annex II (excluding section 4)·Dima Italia S.r.l.·ICIM S.P.A.·2 Basic UDI-DIs

0425-MED-003504-00

Certificate

MDD Annex II (excluding section 4)·Dima Italia S.r.l.·ICIM S.P.A.·13 Basic UDI-DIs

0425-MDR-030055-00

Certificate

MDR QMS·U-Care Medical Srl·ICIM S.P.A.

0425-MDR-030020-00

Certificate

MDR QMS·ENABLE INNOVATIONS SRL·ICIM S.P.A.

0425-MDR-030041-00

Certificate

MDR QMS·New Idem Srl·ICIM S.P.A.

0425-MDR-030033-00

Certificate

MDR QMS·XENIA REPLY S.r.l.·ICIM S.P.A.

0425-MDR-030027-00

Certificate

MDR QA·SOGEVA Srl·ICIM S.P.A.

0425-MDR-030023-00

Certificate

MDR QA·NOVYSTEM S.p.A.·ICIM S.P.A.

0425-MDR-030024-00

Certificate

MDR QMS·Saeg srl·ICIM S.P.A.

0425-MDR-030015-00

Certificate

MDR QMS·WORLD WORK SRL·ICIM S.P.A.

0425-MED-004428-00

Certificate

MDD Annex V·FARMAZAN COSMOCEUTICI SRL·ICIM S.P.A.·1 Basic UDI-DI

0425-MED-003637-00

Certificate

MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·11 Basic UDI-DIs

0425-;MED-003637-00

Certificate

MDD Annex II (excluding section 4)·D.Z. MEDICALE S.R.L.·ICIM S.P.A.·1 Basic UDI-DI