Notified Body
NB 1936
🇮🇹 Italy
TUV Rheinland Italia SRL
Via Mattei, 3, 20010 - Pogliano Milanese (MI), Italy
View on EUDAMED
Updated Oct 2, 2021
Certificates
69
Valid
49
Expiring < 6mo
0
Expired
18
Basic UDI-DIs
70
Devices
77
Manufacturers
60
Cert. Types
5
Basic Information
- Address
- Via Mattei, 3, 20010 - Pogliano Milanese (MI), Italy
- [email protected]
- Phone
- +39 02 9396871
- Website
- www.tuvitalia.com
Regulatory Overview
Regulation
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Eu Mdd
69
Eu Mdr
1
Classification
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Eu Md Class 2a
40
Eu Md Class 2b
27
Eu Md Class 1
3
Device Types
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Certificate Health
Total
69
Valid
49
Expiring < 6mo
0
Expired / Withdrawn
19
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 60124595 | Cometa S.r.l. | Dec 03, 2022 | |||
| MDD Annex V | DD601252910001 | Koolcare Technology Co., Ltd. | Jan 10, 2023 | |||
| MDD Annex II (excluding section 4) | HD 60139155 | Carewill, Lda | Sep 05, 2023 | |||
| MDD Annex V | DD 60133335 | Oasipor - Medical, S.A. | Oct 27, 2023 | |||
| MDD Annex V | DD 60135036 | GEM SRL | Dec 13, 2023 | |||
| MDD Annex V | DD60136132 | Aries srl | Mar 18, 2024 | |||
| MDD Annex II (excluding section 4) | HD 60149137 | Fiterman Pharma SRL | May 25, 2024 | |||
| MDD Annex II (excluding section 4) | HD60149137 | Fiterman Pharma SRL | May 25, 2024 | |||
| MDD Annex V | DD60149886 | Dam S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD60148872 | Techlamed S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD60149833 | RUNNER SRL | May 26, 2024 | |||
| MDD Annex V | DD601490320001 | Wuxi Medical Instrument Factory Co.,Ltd. | May 26, 2024 | |||
| MDD Annex V | M040499 | Roosin Medical Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 15051239011 | Roosin Medical Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 16958868781047 | Roosin Medical Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD601490160001 | Roosin Medical Co., Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD 60155893 | Diametros Medical S.r.l. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD 60147921 | Changzhou Wujin Jinxingda Medical Appliance Co.,Ltd. | May 26, 2024 | |||
| MDR QMS | ITH 1343804 1 | CARDIO CALM S.R.L. | MDR | Jul 2024 | Apr 21, 2027 | Supplemented |
| MDR QMS | ITH 1984728 1 | Pikdare S.p.A. | MDR | Nov 2024 | May 02, 2027 | Amended |
| MDR QMS | ITH 1024597 1 | Asensus Surgical Italia S.r.l. | MDR | Jul 2024 | Jun 30, 2027 | Supplemented |
| MDR QMS | ITH 2379777 1 | Age Solutions Srl | MDR | Oct 2024 | Jul 18, 2027 | Supplemented |
| MDR QMS | ITH 1344141 1 | Meta Ergonomica srl | MDR | Dec 2022 | Jul 19, 2027 | Supplemented |
| MDR QMS | ITH 2409169 1 | Roncadelle Operations Srl | MDR | Jul 2022 | Jul 25, 2027 | Issued |
| MDR QA | ITD 2406494 1 | AUTEL S.r.l. | MDR | Sep 2022 | Sep 08, 2027 | Supplemented |
| MDR QMS | ITH 2373551 1 | Advanced Osteotomy Tools - AOT AG | MDR | Feb 2023 | Oct 18, 2027 | Withdrawn |
| MDR QMS | ITH 2378440 1 | DataRiver S.r.l. | MDR | Feb 2024 | Nov 20, 2027 | Supplemented |
| MDR QMS | ITH 1281809 1 | OSCAR BOSCAROL SRL | MDR | Feb 2023 | Nov 21, 2027 | Supplemented |
| MDR QMS | ITH 1450762 1 | Sky Medical a.s. | MDR | Jun 2024 | Nov 22, 2027 | Supplemented |
| MDR QMS | ITH 2402375 1 | I.M.D. GENERATORS S.R.L. | MDR | Feb 2024 | Dec 05, 2027 | Supplemented |
| MDR QMS | ITH 2456456 1 | Micronica Srl | MDR | Jan 2023 | Dec 14, 2027 | Supplemented |
| MDR QMS | ITH 1450935 1 | WHTcare SA | MDR | Jan 2023 | Jan 02, 2028 | Supplemented |
| MDR QMS | ITH 1344294 1 | I.A.C.E.R. Srl | MDR | Mar 2024 | Jan 15, 2028 | Supplemented |
| MDR QMS | ITH 1344699 1 | Intersurgical SpA | MDR | Feb 2024 | Jan 24, 2028 | Supplemented |
| MDR QA | ITD 1450757 1 | Service Med SrL | MDR | Jan 2024 | Jan 26, 2028 | Supplemented |
| MDR QA | ITD 2429525 1 | Linear S.r.l. | MDR | Feb 2023 | Feb 02, 2028 | Supplemented |
| MDR QMS | ITH 1343248 1 | Hydra srl | MDR | Feb 2023 | Feb 02, 2028 | Supplemented |
| MDR QMS | ITH 2405969 1 | MR DOC S.R.L. | MDR | Nov 2023 | Mar 06, 2028 | Supplemented |
| MDR QA | ITD 1344656 1 | SPECTRUM MEDICAL SRL | MDR | Sep 2024 | Apr 08, 2028 | Supplemented |
| MDR QMS | ITH 1343070 1 | IONCLINICS & DEIONIC, S.L. | MDR | Jul 2024 | Apr 24, 2028 | Supplemented |
| MDR QMS | ITH 2429564 1 | NEURANIX S.R.L. | MDR | May 2023 | May 17, 2028 | Supplemented |
| MDR QMS | ITH 2465616 2 | FRI.MED. S.R.L. | MDR | Oct 2023 | Jul 18, 2028 | Supplemented |
| MDR QMS | ITH 2465616 1 | FRI.MED. S.R.L. | MDR | Oct 2023 | Jul 18, 2028 | Supplemented |
| MDR QMS | ITH 2453837 1 | RAR s.r.l. | MDR | Jul 2023 | Jul 20, 2028 | Supplemented |
| MDR QMS | ITH 2426703 1 | Comerge AG | MDR | Jul 2023 | Jul 23, 2028 | Supplemented |
| MDR QMS | ITH 1344197 1 | G-Squared SRL | MDR | Jan 2024 | Aug 08, 2028 | Supplemented |
| MDR QMS | ITH 1343526 1 | Med-Logix Srl | MDR | Dec 2023 | Oct 16, 2028 | Supplemented |
| MDR QA | ITD 1450390 1 | GEM SRL | MDR | Nov 2023 | Nov 14, 2028 | Supplemented |
| MDR QMS | ITH 2492603 1 | A.T.S. Applicazione Tecnologie Speciali s.r.l. | MDR | May 2024 | Dec 10, 2028 | Issued |
| MDR QMS | ITH 2459334 1 | Linearbeam srl | MDR | Feb 2024 | Feb 20, 2029 | Supplemented |
| MDR QMS | ITH 2477191 1 | Bonebridge AG | MDR | Dec 2024 | Feb 28, 2029 | Supplemented |
| MDR QA | ITD 2423536 1 | Sidam S.R.L. | MDR | Oct 2024 | Mar 17, 2029 | Supplemented |
| MDR QMS | ITH 2423536 1 | Sidam S.R.L. | MDR | Jul 2024 | Mar 17, 2029 | Issued |
| MDR QMS | ITH 2534789 1 | Intersurgical Ltd | MDR | Apr 2024 | Apr 11, 2029 | Supplemented |
| MDR QMS | ITH 1024592 1 | Eufoton Srl | MDR | May 2024 | May 15, 2029 | Issued |
| MDR QMS | ITH 2473502 1 | MEDI-CARE SOLUTIONS SRL | MDR | Dec 2024 | May 19, 2029 | Supplemented |
| MDR QA | ITD 1344601 1 | TT Tooth Transformer srl | MDR | May 2024 | May 27, 2029 | Issued |
| MDR QMS | ITH 2308229 1 | MEDILAB-PD SRL | MDR | Jul 2024 | Jul 07, 2029 | Issued |
| MDR QMS | ITH 1503348 1 | Zakłady Farmaceutyczne Polpharma SA | MDR | Sep 2024 | Jul 17, 2029 | Supplemented |
| MDR QMS | ITH 1450769 1 | Imaginalis Srl | MDR | Jul 2024 | Jul 18, 2029 | Issued |
| MDR QA | ITD 1344523 1 | Dispotech srl | MDR | Jul 2024 | Jul 29, 2029 | Issued |
| MDR Technical Documentation | ITI 2486145 1 | B. & B. Dental S.r.l. | MDR | Aug 2024 | Jul 31, 2029 | Issued |
| MDR QMS | ITH 2486145 1 | B. & B. Dental S.r.l. | MDR | Aug 2024 | Jul 31, 2029 | Issued |
| MDR QMS | ITH 1343916 1 | AFERETICA S.R.L. | MDR | Oct 2024 | Oct 17, 2029 | Issued |
| MDR QMS | ITH 1343191 1 | CARDIOLINE | MDR | Oct 2024 | Oct 20, 2029 | Issued |
| MDR QA | ITD 1343612 1 | Dompé farmaceutici s.p.a. | MDR | Oct 2024 | Oct 22, 2029 | Supplemented |
| MDR QMS | ITH 1342906 1 | ComfTech | MDR | Nov 2024 | Nov 25, 2029 | Issued |
| MDR QMS | ITH 1986726 1 | Empatica S.r.L. | MDR | Nov 2024 | Nov 28, 2029 | Issued |
| MDR Technical Documentation | ITI24861451 | B. & B. Dental S.r.l. | — |