Notified Body
NB 0425
🇮🇹 Italy
ICIM S.P.A.
Piazza Don Enrico Mapelli, 75, 20099 - Sesto San Giovanni (MI), Italy
View on EUDAMED
Updated Dec 9, 2022
Certificates
32
Valid
8
Expiring < 6mo
0
Expired
23
Basic UDI-DIs
86
Devices
86
Manufacturers
19
Cert. Types
4
Basic Information
- Address
- Piazza Don Enrico Mapelli, 75, 20099 - Sesto San Giovanni (MI), Italy
- [email protected]
- Phone
- +39 02 725341
- Website
- www.icim.it
Regulatory Overview
Regulation
Loading...
Eu Mdd
86
Classification
Loading...
Eu Md Class 2b
63
Eu Md Class 2a
22
Eu Md Class 1
1
Device Types
Loading...
Certificate Health
Total
32
Valid
8
Expiring < 6mo
0
Expired / Withdrawn
23
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 0425-MED-003242-00 | SANADEN SRLS | Nov 20, 2022 | |||
| MDD Annex II (excluding section 4) | 0425-MED-3504-00 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003504-00 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | MED-003504-00 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003503-00 | Tecno-Gaz S.p.A | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-00350400 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425.MED-003504-00 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003504 | Dima Italia S.r.l. | Jan 31, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003600-00 | MedCu Technologies | May 07, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003600-00 | MedCu Technologies | May 07, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-004434-00 | Tecno-Gaz S.p.A | May 25, 2024 | |||
| MDD Annex V | 0425-MED-004428-00 | FARMAZAN COSMOCEUTICI SRL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-003637-00 | D.Z. MEDICALE S.R.L. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-;MED-003637-00 | D.Z. MEDICALE S.R.L. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-004405-00 | Recordati Industria Chimica e Farmaceutica S.p.A | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-004405-00 | Recordati Industria Chimica e Farmaceutica S.p.A | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE:0425-MED-003637-00 | D.Z. MEDICALE S.R.L. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-M ED-004434-00 | Tecno-Gaz S.p.A | May 26, 2024 | |||
| MDD Annex V | 0425-MED-004222-00 | Medical2Market B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0425-MED-004106-00 | MONTEFARMACO OTC SPA | May 26, 2024 | |||
| MDD Annex V | 0425-MED-004179-OO | MONTEFARMACO OTC SPA | May 26, 2024 | |||
| MDD Annex V | 0425-MED-004179-00 | MONTEFARMACO OTC SPA | May 26, 2024 | |||
| MDD Annex V | ICIM-13485-050028-00 | Stroke2Prevent | Sep 13, 2025 | |||
| MDR QMS | 0425-MDR-030015-00 | WORLD WORK SRL | MDR | Jan 2023 | Jan 25, 2028 | Issued |
| MDR QMS | 0425-MDR-030020-00 | ENABLE INNOVATIONS SRL | MDR | Feb 2023 | Feb 26, 2028 | Issued |
| MDR QA | 0425-MDR-030023-00 | NOVYSTEM S.p.A. | MDR | Apr 2023 | Apr 27, 2028 | Issued |
| MDR QMS | 0425-MDR-030024-00 | Saeg srl | MDR | May 2023 | May 07, 2028 | Issued |
| MDR QA | 0425-MDR-030027-00 | SOGEVA Srl | MDR | May 2023 | May 10, 2028 | Issued |
| MDR QMS | 0425-MDR-030033-00 | XENIA REPLY S.r.l. | MDR | May 2023 | May 25, 2028 | Issued |
| MDR QMS | 0425-MDR-030041-00 | New Idem Srl | MDR | Sep 2023 | Sep 21, 2028 | Issued |
| MDR QMS | 0425-MDR-030055-00 | U-Care Medical Srl | MDR | Nov 2023 | Nov 19, 2028 | Issued |
| MDD Annex V | 0425-MED-004425-00 | USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l. | Dec 31, 2028 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Dima Italia S.r.l. | 🇮🇹 Italy | 6 | 0 | 0 |
| MONTEFARMACO OTC SPA | 🇮🇹 Italy | 3 | 0 | 0 |
| Tecno-Gaz S.p.A | 🇮🇹 Italy | 3 | 0 | 0 |
| D.Z. MEDICALE S.R.L. | 🇮🇹 Italy | 3 | 0 | 0 |
| MedCu Technologies | 🇮🇱 Israel | 2 | 0 | 0 |
| Recordati Industria Chimica e Farmaceutica S.p.A | 🇮🇹 Italy | 2 | 0 | 0 |
| Stroke2Prevent | 🇳🇱 Netherlands | 1 | 0 | 0 |
| Medical2Market B.V. | 🇳🇱 Netherlands | 1 | 0 | 0 |
| SANADEN SRLS | 🇮🇹 Italy | 1 | 0 | 0 |
| FARMAZAN COSMOCEUTICI SRL | 🇮🇹 Italy | 1 | 0 | 0 |
| USP - UNION OF PHARMACEUTICAL SCIENCES S.r.l. | 🇮🇹 Italy | 1 | 0 | 0 |
| WORLD WORK SRL | 🇮🇹 Italy | 1 | 1 | 0 |
| Saeg srl | 🇮🇹 Italy | 1 | 1 | 0 |
| NOVYSTEM S.p.A. | 🇮🇹 Italy | 1 | 1 | 0 |
| SOGEVA Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| XENIA REPLY S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| New Idem Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| ENABLE INNOVATIONS SRL | 🇮🇹 Italy | 1 | 1 | 0 |
| U-Care Medical Srl | 🇮🇹 Italy | 1 | 1 | 0 |