Notified Body
NB 0373
🇮🇹 Italy
ISTITUTO SUPERIORE DI SANITA'
Viale Regina Elena, 299, 00161 - ROMA, Italy
View on EUDAMED
Updated Oct 2, 2021
Certificates
155
Valid
38
Expiring < 6mo
0
Expired
102
Basic UDI-DIs
506
Devices
621
Manufacturers
43
Cert. Types
9
Basic Information
- Address
- Viale Regina Elena, 299, 00161 - ROMA, Italy
- [email protected]
- Phone
- +39 06 49906146
- Website
- www.iss.it
Regulatory Overview
Regulation
Loading...
Eu Mdd
487
Eu Mdr
19
Classification
Loading...
Eu Md Class 3
319
Eu Md Class 2a
115
Eu Md Class 2b
48
Eu Md Class 1
24
Device Types
Loading...
Certificate Health
Total
155
Valid
38
Expiring < 6mo
0
Expired / Withdrawn
102
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | QCT -0030-17 | Eurosirel Spa | Apr 17, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0030-17 | Eurosirel Spa | Apr 17, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0030-17 / EPG-0210-19 | Eurosirel Spa | Apr 17, 2022 | |||
| MDD Annex II Section 4 | EPG-0210-19 | Eurosirel Spa | Apr 17, 2022 | |||
| MDD Annex II Section 4 | EPG021019 QCT0030170219 | Eurosirel Spa | Apr 17, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0036-17 | BETATEX SPA | May 07, 2022 | |||
| MDD Annex II Section 4 | EPG-0313-20-03-21 | NYUMA PHARMA S.R.L. | May 08, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0161-20-02-20 | NYUMA PHARMA S.R.L. | May 08, 2022 | |||
| MDD Annex II Section 4 | EPG-0313-20-03-21 | NYUMA PHARMA S.R.L. | May 08, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0161-20-02-20 | NYUMA PHARMA S.R.L. | May 08, 2022 | |||
| MDD Annex II Section 4 | 004917 | Medicap S.r.l | Jul 12, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0066-17 | Fin-ceramica faenza spa | Dec 12, 2022 | |||
| MDD Annex II Section 4 | EPG-0066-17 | Fin-ceramica faenza spa | Dec 12, 2022 | |||
| MDD Annex II Section 4 | EPG-0065-17 | Fin-ceramica faenza spa | Dec 12, 2022 | |||
| MDD Annex II Section 4 | EPG-0064-17 | Fin-ceramica faenza spa | Dec 12, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-066-17 | Fin-ceramica faenza spa | Dec 12, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0067-17 | Labomar S.p.A. | Dec 13, 2022 | |||
| MDD Annex V | QPZ-1898-17 | GENERAL TOPICS SRL | Dec 14, 2022 | |||
| MDD Annex V | QPZ-1989-17 | GENERAL TOPICS SRL | Dec 14, 2022 | |||
| MDD Annex II (excluding section 4) | QCT-0081-18-17-18 | Drugs Minerals and Generics Italia S.r.l. | Mar 21, 2023 | |||
| MDD Annex II (excluding section 4) | Lettera approvazione ISS del 26/01/2022 Prot. 3131/ON0373.ON12 MCE 95/22 | Drugs Minerals and Generics Italia S.r.l. | Mar 21, 2023 | |||
| MDD Annex II Section 4 | EPG-0188-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0082-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0187-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0251-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0252-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0408-21 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0136-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0135-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0321-21 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0200-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0199-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0091-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0253-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0134-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0185-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0399-21 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II Section 4 | EPG-0184-19 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II (excluding section 4) | EPG-0082-18 | Mastelli S.r.l. | Mar 26, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0090-18-03-18 | Drugs Minerals and Generics Italia S.r.l. | Jun 24, 2023 | |||
| MDD Annex II (excluding section 4) | Lettera approvazione ISS del 04/01/2024 Prot. 216/ON-ISS.12.00 MCE 4/24 | Drugs Minerals and Generics Italia S.r.l. | Jun 24, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0090-18- 06-18 | Drugs Minerals and Generics Italia S.r.l. | Jun 24, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0090-18-07-18 | Drugs Minerals and Generics Italia S.r.l. | Jun 24, 2023 | |||
| MDD Annex II Section 4 | EPG-0176-18 | OPKO HEALTH SPAIN S.L.U. | Oct 28, 2023 | |||
| MDD Annex III | QCT-0103-18 | OPKO HEALTH SPAIN S.L.U. | Oct 29, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0103-08 | OPKO HEALTH SPAIN S.L.U. | Oct 29, 2023 | |||
| MDD Annex II Section 4 | EPG-0177-18 | OPKO HEALTH SPAIN S.L.U. | Oct 29, 2023 | |||
| MDD Annex V | QPZ-01910-18 | MDT Int'l SA | Dec 17, 2023 | |||
| MDD Annex II Section 4 | EPG-0182-18 | GENERAL TOPICS SRL | Dec 26, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0110-18 | GENERAL TOPICS SRL | Dec 26, 2023 | |||
| MDD Annex II (excluding section 4) | QCT-0113-19 | Panin Srl | Feb 17, 2024 | |||
| MDD Annex V | QPZ-1911-19-13-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-25-20 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-12-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | 05/09/2023 – Prot. 40029 – ON-ISS.12.00 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-22-20 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | 26/06/2023 – Prot. 30262– ON-ISS.12.00 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-09-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-01-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-23-20 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | 26/06/2023 – Prot. 30261– ON-ISS.12.00 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-08-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex V | QPZ-1911-19-06-19 | Drugs Minerals and Generics Italia S.r.l. | Apr 14, 2024 | |||
| MDD Annex II (excluding section 4) | qct-0120-19 | G P S S.R.L. | May 20, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0120-19 | G P S S.R.L. | May 20, 2024 | |||
| MDD Annex II Section 4 | EPG-0342-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-03-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex V | QPZ-1936-20-addendum 03-20 | DEVINTEC SAGL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0176-21 | MDT Int'l SA | May 26, 2024 | |||
| MDD Annex V | QPS-0500-19 | Tecnoclínic SA | May 26, 2024 | |||
| MDD Annex V | QPZ-1940-20 | Effik Benelux NV/SA | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0341-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-02-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0344-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-04-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0393-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-07-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0340-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-01-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0343-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-05-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0345-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21-06-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0355-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0170-21 | Savio Industrial S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT016521 | SWEDEN & MARTINA S.P.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | EPG032621 | SWEDEN & MARTINA S.P.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT016521 | SWEDEN & MARTINA S.P.A. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT016521 | SWEDEN & MARTINA S.P.A. | May 26, 2024 | |||
| MDD Annex V | QPZ-1956-21 | Cosmo Technologies | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0148-20 | iVis Technologies S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0134-19 | Drex Pharma Srl | May 26, 2024 | |||
| MDD Annex V | QPZ-1920-19 | GEM SRL | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0242-19 | GEM SRL | May 26, 2024 | |||
| MDD Annex II Section 4 | QCT-0133-19 | GEM SRL | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG0242-19 | GEM SRL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0161-20 | NYUMA PHARMA S.R.L. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0308-20 | NYUMA PHARMA S.R.L. | May 26, 2024 | |||
| MDD Annex II Section 4 | EPG-0308-20 | NYUMA PHARMA S.R.L. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | QCT-0161-20 | NYUMA PHARMA S.R.L. | May 26, 2024 | |||
| MDD Annex V | QPS-0500 | Tecnoclínic SA | May 26, 2024 | |||
| MDR Product Verification | CVP000522 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR Type Examination | CVT000122 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR Product Verification | CVP000322 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR Product Verification | CVP000422 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR Product Verification | CVP000222 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR Product Verification | CVP000122 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Jul 2023 | Aug 03, 2027 | Amended |
| MDR QMS | CSQ0001220223 | BETATEX SPA | MDR | Feb 2023 | Oct 23, 2027 | Supplemented |
| MDR QMS | CSQ0002220223 | Medicap S.r.l | MDR | Feb 2023 | Dec 22, 2027 | Supplemented |
| MDR Technical Documentation | CVD000122 | Medicap S.r.l | MDR | Dec 2022 | Dec 22, 2027 | Issued |
| MDR QMS | CSQ0003220123 | MEDI-LINE S.r.l. | MDR | Jan 2023 | Dec 27, 2027 | Supplemented |
| MDR QMS | CSQ000322 | MEDI-LINE S.r.l. | MDR | Dec 2022 | Dec 27, 2027 | Issued |
| MDD Annex II Section 4 | EPG-0093-18 | I.R.A. Istituto Ricerche Applicate S.p.A. | Dec 31, 2027 | |||
| MDR QMS | CSQ0005230223 | SILDEHA Pharma Srl | MDR | Feb 2023 | Jan 18, 2028 | Supplemented |
| MDR QMS | CSQ0004230523 | S.A.L.F. S.p.A. Laboratorio Farmacologico | MDR | May 2023 | Jan 19, 2028 | Supplemented |
| MDR Technical Documentation | CVD0002230523 | S.A.L.F. S.p.A. Laboratorio Farmacologico | MDR | May 2023 | Jan 19, 2028 | Supplemented |
| MDR QMS | CSQ0006230223 | Italfarmacia srl | MDR | Mar 2023 | Mar 05, 2028 | Supplemented |
| MDR Technical Documentation | CVD000323 | Micromed srl | MDR | Mar 2023 | Mar 07, 2028 | Issued |
| MDR QMS | CSQ000723 | Micromed srl | MDR | Mar 2023 | Mar 07, 2028 | Issued |
| MDR Technical Documentation | CVD000423 | Fin-ceramica faenza spa | MDR | Mar 2023 | Mar 12, 2028 | Issued |
| MDR Technical Documentation | CVD000523 | Fin-ceramica faenza spa | MDR | Mar 2023 | Mar 12, 2028 | Issued |
| MDR QMS | CSQ000823 | Fin-ceramica faenza spa | MDR | Mar 2023 | Mar 12, 2028 | Issued |
| MDR QMS | CSQ0009230223 | ABOCA S.P.A. SOCIETÀ AGRICOLA | MDR | Dec 2023 | Mar 26, 2028 | Supplemented |
| MDR Type Examination | CVT000223 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Apr 2023 | Apr 05, 2028 | Issued |
| MDR Product Verification | CVP000623 | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | MDR | Apr 2023 | Apr 05, 2028 | Issued |
| MDR QMS | CSQ001123 | Farmigea S.p.A. | MDR | Jun 2023 | Jun 13, 2028 | Issued |
| MDR QMS | CSQ001223 | PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S.A | MDR | Jul 2023 | Jun 26, 2028 | Issued |
| MDR QMS | CSQ001323 | ASSUT EUROPE SPA | MDR | Aug 2023 | Aug 07, 2028 | Issued |
| MDR Technical Documentation | CVD001423 | ASSUT EUROPE SPA | MDR | Aug 2023 | Aug 07, 2028 | Issued |
| MDR QMS | CSQ002024 | SIFI S.p.A. | MDR | May 2024 | Sep 21, 2028 | Issued |
| MDR Technical Documentation | CVD001523 | SIFI S.p.A. | MDR | Sep 2023 | Sep 21, 2028 | Issued |
| MDR QMS | CSQ001423 | Artsana S.p.A. | MDR | Nov 2023 | Nov 01, 2028 | Issued |
| MDR Technical Documentation | CVD002123 | B. & B. Dental S.r.l. | MDR | Nov 2023 | Nov 27, 2028 | Issued |
| MDR QMS | CSQ001523 | B. & B. Dental S.r.l. | MDR | Nov 2023 | Nov 27, 2028 | Issued |
| MDR QMS | CSQ001623 | Noventure SL | MDR | Dec 2023 | Dec 21, 2028 | Issued |
| MDR Technical Documentation | CVD002323 | Noventure SL | MDR | Dec 2023 | Dec 21, 2028 | Issued |
| MDR QMS | CSQ0017240124 | L. Molteni & C. dei F.lli Alitti - Società di Esercizio - S.p.A. | MDR | Jan 2024 | Jan 08, 2029 | Supplemented |
| MDR QMS | CSQ002424 | Bruschettini s.r.l. | MDR | Jul 2024 | Feb 07, 2029 | Issued |
| MDR QA | CGP000124 | Tecnoclínic SA | MDR | Apr 2024 | Apr 15, 2029 | Issued |
| MDR Technical Documentation | CVD002824 | Alfa Intes Industria Terapeutica Splendore S.r.l. | MDR | Jun 2024 | Jun 13, 2029 | Issued |
| MDR Technical Documentation | CVD 0028-24 | Alfa Intes Industria Terapeutica Splendore S.r.l. | — | |||
| MDR Technical Documentation | CVD 0014-23 | ASSUT EUROPE SPA | — | |||
| MDR Technical Documentation | CVD 0021-23 | B. & B. Dental S.r.l. | — | |||
| MDR Technical Documentation | CVD 0023-23 | Noventure SL | — | |||
| MDR Technical Documentation | CVD 0015-23 | SIFI S.p.A. | — | |||
| MDR Technical Documentation | CSQ 0007-23 | Micromed srl | — | |||
| MDR Technical Documentation | CVD000223 | S.A.L.F. S.p.A. Laboratorio Farmacologico | — | |||
| MDR Technical Documentation | CVD 0002-23 | S.A.L.F. S.p.A. Laboratorio Farmacologico | — | |||
| MDR Type Examination | — | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | — | |||
| MDR Technical Documentation | CVD 0004-23 | Fin-ceramica faenza spa | — | |||
| MDR Technical Documentation | CVD 0005-23 | Fin-ceramica faenza spa | — | |||
| MDR Technical Documentation | cvd0001-22 | Medicap S.r.l | — | |||
| MDR Type Examination | — | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | — | |||
| MDR Type Examination | — | FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA | — |