Notified Body
NB 0426
🇮🇹 Italy
ITALCERT SRL
Viale Sarca, 336, 20126 - MILANO, Italy
View on EUDAMED
Updated Jan 13, 2022
Certificates
84
Valid
42
Expiring < 6mo
0
Expired
28
Basic UDI-DIs
329
Devices
1392
Manufacturers
39
Cert. Types
6
Basic Information
- Address
- Viale Sarca, 336, 20126 - MILANO, Italy
- [email protected]
- Phone
- +39 02 66104876
- Website
- www.italcert.it
Regulatory Overview
Regulation
Loading...
Eu Mdd
298
Eu Mdr
31
Classification
Loading...
Eu Md Class 2a
250
Eu Md Class 2b
53
Eu Md Class 3
25
Eu Md Class 1
1
Device Types
Loading...
Certificate Health
Total
84
Valid
42
Expiring < 6mo
0
Expired / Withdrawn
28
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | 375-00-05-DM | S.I.I.T. srl | Nov 26, 2022 | |||
| MDD Annex II (excluding section 4) | 074-02-02-DM | ATENA LUX S.R.L. | Feb 02, 2023 | |||
| MDD Annex II (excluding section 4) | 074-02-03 | ATENA LUX S.R.L. | Feb 02, 2023 | |||
| MDD Annex V | 382.00.02.DM | MAYOLY PHARMA FRANCE | Feb 25, 2023 | |||
| MDD Annex II (excluding section 4) | 397-00-03-DM | Alfakjn S.r.l. | Oct 29, 2023 | |||
| MDD Annex II Section 4 | 398-00-03-DM | Alfakjn S.r.l. | Oct 29, 2023 | |||
| MDD Annex II (excluding section 4) | 399-00-00-DM | SeedIMPULSE SA | Nov 12, 2023 | |||
| MDD Annex V | 095-02-06-DM | S.I.I.T. srl | Nov 20, 2023 | |||
| MDD Annex II (excluding section 4) | 098-02-00-DM | Air Liquide Sanità Service S.p.A. | Jan 12, 2024 | |||
| MDD Annex II (excluding section 4) | 102-02-00-DM | Air Liquide Sanità Service S.p.A. | May 06, 2024 | |||
| MDD Annex V | 346-01-00 | MAYOLY PHARMA FRANCE | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | 545-00-00-DM | Alfakjn S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 563-00-00-DM | Intelligenza Trasparente S.r.l. | May 26, 2024 | |||
| MDD Annex V | 178-02-00-DM | Biomedical S.r.l. | May 26, 2024 | |||
| MDD Annex V | 494-00-00-00 | CF Pharma Ireland Ltd | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 447-00-02 | Biomech Innovations AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 447-00-02-DM | Biomech Innovations AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 0557-00-00-DM | EPISCAN S.R.L. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 481-00-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 330-01-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 278-01-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 067-03-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 064-03-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 066-03-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 145-02-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 526-00-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 176-02-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 184-02-00-DM | Air Liquide Sanità Service S.p.A. | May 26, 2024 | |||
| MDR QMS | 050-00-00-MDR | NTC Srl | MDR | Jun 2024 | Jun 09, 2026 | Issued |
| MDR QMS | 001-00-01-MDR | Adler Ortho S.p.A | MDR | Oct 2023 | Mar 31, 2027 | Supplemented |
| MDR QMS | 002-00-00-MDR | Permedica S.p.A | MDR | Jul 2022 | Jul 04, 2027 | Issued |
| MDR QMS | 003-00-10-MDR | STERYLAB S.R.L. | MDR | Apr 2024 | Sep 07, 2027 | Supplemented |
| MDR QMS | 006-00-01-MDR | Mt Ortho | MDR | Nov 2022 | Oct 16, 2027 | Amended |
| MDR QMS | 005-00-01-MDR | TECNOFAR s.p.a. | MDR | Dec 2024 | Oct 19, 2027 | Supplemented |
| MDR QMS | 004-00-02-MDR | MEDICAL CONSULTING SRL | MDR | Mar 2023 | Oct 26, 2027 | Supplemented |
| MDR QMS | 007-00-03-MDR | BIOTEC S.R.L. | MDR | May 2024 | Dec 20, 2027 | Supplemented |
| MDR QMS | 009-00-10-MDR | GRUPPO FARMAIMPRESA SRL | MDR | Jan 2025 | Jan 09, 2028 | Supplemented |
| MDR QMS | 010-00-06-MDR | GRUPPO FARMAIMPRESA SRL | MDR | Jun 2024 | Jan 09, 2028 | Supplemented |
| MDR Technical Documentation | 012-00-00-MDR | STERYLAB S.R.L. | MDR | Feb 2023 | Feb 06, 2028 | Issued |
| MDR QMS | 011-00-00-MDR | STERYLAB S.R.L. | MDR | Feb 2023 | Feb 06, 2028 | Issued |
| MDR Technical Documentation | 014-00-00-MDR | LSM-MED S.r.l. | MDR | Mar 2023 | Mar 02, 2028 | Issued |
| MDR QMS | 013-00-00-MDR | LSM-MED S.r.l. | MDR | Mar 2023 | Mar 02, 2028 | Issued |
| MDR QMS | 015-00-00-MDR | ATENA LUX S.R.L. | MDR | Mar 2023 | Mar 20, 2028 | Issued |
| MDR QMS | 016-00-01-MDR | EVOLUTIS | MDR | Nov 2024 | Apr 05, 2028 | Supplemented |
| MDR Technical Documentation | 017-00-00-MDR | EVOLUTIS | MDR | Apr 2023 | Apr 05, 2028 | Issued |
| MDR QMS | 018-00-00-MDR | LIMACORPORATE S.p.A. | MDR | May 2023 | May 03, 2028 | Issued |
| MDR Technical Documentation | 021-00-02-MDR | GRUPPO FARMAIMPRESA SRL | MDR | Feb 2024 | Jun 21, 2028 | Supplemented |
| MDR Technical Documentation | 023-00-00-MDR | MicroPort Orthopedics Inc. | MDR | Jul 2023 | Jul 03, 2028 | Supplemented |
| MDR QMS | 022-00-00-MDR | MicroPort Orthopedics Inc. | MDR | Jul 2023 | Jul 03, 2028 | Issued |
| MDR QMS | 024-00-00-MDR | ANGIOLOGICA B.M. S.R.L. | MDR | Jul 2023 | Jul 05, 2028 | Issued |
| MDR Technical Documentation | 025-00-00-MDR | ANGIOLOGICA B.M. S.R.L. | MDR | Jul 2023 | Jul 05, 2028 | Issued |
| MDR QA | 030-00-00-MDR | STERYLAB S.R.L. | MDR | Aug 2023 | Aug 28, 2028 | Issued |
| MDR QMS | 027-00-00-MDR | SIFI S.p.A. | MDR | Sep 2023 | Aug 31, 2028 | Issued |
| MDR QMS | 029-00-00-MDR | CIZETA SURGICAL S.r.l. | MDR | Sep 2023 | Sep 14, 2028 | Issued |
| MDR Technical Documentation | 032-00-00-MDR | STERIFY S.R.L. | MDR | Oct 2023 | Oct 05, 2028 | Issued |
| MDR QMS | 031-00-00-MDR | STERIFY S.R.L. | MDR | Oct 2023 | Oct 05, 2028 | Issued |
| MDR QMS | 037-00-00-MDR | Chiesi Farmaceutici S.p.A. | MDR | Dec 2023 | Dec 12, 2028 | Issued |
| MDD Annex V | 494-00-00-DM | CF Pharma Ireland Ltd | Dec 31, 2028 | |||
| MDR QMS | 039-00-00-MDR | NOOS S.r.l. | MDR | Jan 2024 | Jan 23, 2029 | Issued |
| MDR QMS | 040-00-00-MDR | NTC Srl | MDR | Feb 2024 | Feb 08, 2029 | Issued |
| MDR QMS | 041-00-00-MDR | Chiesi Farmaceutici S.p.A. | MDR | Feb 2024 | Feb 14, 2029 | Issued |
| MDR QMS | 042-00-00-MDR | MEDES S.r.l. | MDR | Feb 2024 | Feb 19, 2029 | Issued |
| MDR Technical Documentation | 044-00-00-MDR | GreenBone Ortho Spa | MDR | Mar 2024 | Mar 05, 2029 | Issued |
| MDR QMS | 045-00-00-MDR | S.G.M.SRL | MDR | Apr 2024 | Apr 15, 2029 | Issued |
| MDR QMS | 046-00-00-MDR | NTC Srl | MDR | May 2024 | May 07, 2029 | Issued |
| MDR QMS | 049-00-00-MDR | PHARMA LINE Srl | MDR | Jun 2024 | Jun 03, 2029 | Issued |
| MDR QMS | 051-00-00-MDR | Medical Gas Criogenici Srl | MDR | Jul 2024 | Jul 21, 2029 | Issued |
| MDR Technical Documentation | 055-00-00-MDR | EVOLUTIS | MDR | Sep 2024 | Sep 11, 2029 | Issued |
| MDR QMS | 060-00-00-MDR | BRM Extremities S.r.l. | MDR | Sep 2024 | Sep 19, 2029 | Issued |
| MDR QMS | 061-00-00-MDR | GPI S.P.A. | MDR | Oct 2024 | Oct 22, 2029 | Issued |
| MDR QMS | 065-00-00-MDR | S.I.I.T. srl | MDR | Nov 2024 | Nov 20, 2029 | Issued |
| MDR Technical Documentation | 028-00-02-MDR | SIFI S.p.A. | — | |||
| MDR Technical Documentation | 055-00-00-MDR | EVOLUTIS | — | |||
| MDR Technical Documentation | 044-00-00-MDR | GreenBone Ortho Spa | — | |||
| MDR Technical Documentation | 017-00-00-MDR | EVOLUTIS | — | |||
| MDR Technical Documentation | 028-00-00-MDR | SIFI S.p.A. | — | |||
| MDR Technical Documentation | 023-00-00-MDR | MicroPort Orthopedics Inc. | — | |||
| MDR Technical Documentation | 023-00 | MicroPort Orthopedics Inc. | — | |||
| MDR Technical Documentation | 032-00-00MDR | STERIFY S.R.L. | — | |||
| MDR Technical Documentation | CE 021-00-00-MDR | GRUPPO FARMAIMPRESA SRL | — | |||
| MDR Technical Documentation | 025-00-00-MDR | ANGIOLOGICA B.M. S.R.L. | — | |||
| MDR Technical Documentation | — | LSM-MED S.r.l. | — | |||
| MDR Technical Documentation | 012-00-00-MDR | STERYLAB S.R.L. | — | |||
| MDR Technical Documentation | 008-00-01-MDR | BIOTEC S.R.L. | — |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Air Liquide Sanità Service S.p.A. | 🇮🇹 Italy | 12 | 0 | 0 |
| EVOLUTIS | 🇫🇷 France | 5 | 3 | 0 |
| STERYLAB S.R.L. | 🇮🇹 Italy | 5 | 4 | 0 |
| MicroPort Orthopedics Inc. | 🇺🇸 United States | 4 | 2 | 0 |
| LSM-MED S.r.l. | 🇸🇲 San Marino | 3 | 2 | 0 |
| ATENA LUX S.R.L. | 🇮🇹 Italy | 3 | 1 | 0 |
| ANGIOLOGICA B.M. S.R.L. | 🇮🇹 Italy | 3 | 2 | 0 |
| SIFI S.p.A. | 🇮🇹 Italy | 3 | 1 | 0 |
| Alfakjn S.r.l. | 🇮🇹 Italy | 3 | 0 | 0 |
| S.I.I.T. srl | 🇮🇹 Italy | 3 | 1 | 0 |
| NTC Srl | 🇮🇹 Italy | 3 | 3 | 0 |
| GRUPPO FARMAIMPRESA SRL | 🇮🇹 Italy | 2 | 2 | 0 |
| MAYOLY PHARMA FRANCE | 🇫🇷 France | 2 | 0 | 0 |
| Biomech Innovations AG | 🇨🇭 Switzerland | 2 | 0 | 0 |
| STERIFY S.R.L. | 🇮🇹 Italy | 2 | 2 | 0 |
| CF Pharma Ireland Ltd | 🇮🇪 Ireland | 2 | 0 | 0 |
| GreenBone Ortho Spa | 🇮🇹 Italy | 2 | 1 | 0 |
| BIOTEC S.R.L. | 🇮🇹 Italy | 2 | 1 | 0 |
| GRUPPO FARMAIMPRESA SRL | 🇮🇹 Italy | 2 | 1 | 0 |
| Chiesi Farmaceutici S.p.A. | 🇮🇹 Italy | 2 | 2 | 0 |
| STERIFY S.R.L. | 🇮🇹 Italy | 1 | 0 | 0 |
| Biomedical S.r.l. | 🇮🇹 Italy | 1 | 0 | 0 |
| Intelligenza Trasparente S.r.l. | 🇮🇹 Italy | 1 | 0 | 0 |
| SeedIMPULSE SA | 🇨🇭 Switzerland | 1 | 0 | 0 |
| Permedica S.p.A | 🇮🇹 Italy | 1 | 1 | 0 |
| EPISCAN S.R.L. | 🇮🇹 Italy | 1 | 0 | 0 |
| Mt Ortho | 🇮🇹 Italy | 1 | 1 | 0 |
| MEDICAL CONSULTING SRL | 🇮🇹 Italy | 1 | 1 | 0 |
| LIMACORPORATE S.p.A. | 🇮🇹 Italy | 1 | 1 | 0 |
| Adler Ortho S.p.A | 🇮🇹 Italy | 1 | 1 | 0 |
| CIZETA SURGICAL S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| NOOS S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| MEDES S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| S.G.M.SRL | 🇮🇹 Italy | 1 | 1 | 0 |
| PHARMA LINE Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| BRM Extremities S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| GPI S.P.A. | 🇮🇹 Italy | 1 | 1 | 0 |
| Medical Gas Criogenici Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| TECNOFAR s.p.a. | 🇮🇹 Italy | 1 | 1 | 0 |