Notified Body
NB 1370
🇮🇹 Italy
BUREAU VERITAS ITALIA S.P.A.
Viale Monza, 347, 20126 - MILANO (MI), Italy
View on EUDAMED
Updated Aug 4, 2022
Certificates
51
Valid
18
Expiring < 6mo
0
Expired
28
Basic UDI-DIs
434
Devices
446
Manufacturers
36
Cert. Types
6
Basic Information
- Address
- Viale Monza, 347, 20126 - MILANO (MI), Italy
- [email protected]
- Phone
- +39 02 270911
- Website
- www.bureauveritas.it
Regulatory Overview
Regulation
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Eu Mdd
431
Eu Mdr
3
Classification
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Eu Md Class 2b
250
Eu Md Class 2a
165
Eu Md Class 1
16
Eu Md Class 3
3
Device Types
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Certificate Health
Total
51
Valid
18
Expiring < 6mo
0
Expired / Withdrawn
28
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | IT283394 | ITALDEVICE S.R.L. | Jun 13, 2023 | |||
| MDD Annex II (excluding section 4) | IT283394 | ITALDEVICE S.R.L. | Jun 13, 2023 | |||
| MDD Annex II (excluding section 4) | IT288297 | CUREXO, INC. | Sep 13, 2023 | |||
| MDD Annex II (excluding section 4) | IT263051 | Dexcowin | Sep 20, 2023 | |||
| MDD Annex II (excluding section 4) | IT261345 | Prime Color Vision Co., Ltd. | Dec 16, 2023 | |||
| MDD Annex II (excluding section 4) | IT269883 | E-TAKESCARE | May 25, 2024 | |||
| MDD Annex V | IT291369 | B&L Biotech | May 26, 2024 | |||
| MDD Annex V | G20411810034 | BIOPSYBELL SRL | May 26, 2024 | |||
| MDD Annex V | T291369 | B&L Biotech | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT305000 | AGEING TECH SRL | May 26, 2024 | |||
| MDD Annex V | IT291369 | B&L Biotech | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT304926 | Mercury Produzione Srl | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT296501 – 3 | ELITS GROUP SRL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT277362-1 | Coreline Soft Co., Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | IT279221 | Akern Srl | May 26, 2024 | |||
| MDD Annex II Section 4 | IT277921 | Akern Srl | May 26, 2024 | |||
| MDD Annex V | IT273886 | SECURIMED | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT273023 | Woosung Medi-Filtech | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT273023 | Woosung Medi-Filtech | May 26, 2024 | |||
| MDD Annex V | IT266961 | TEHNO BIONIC SRL | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT305947 | Rossiello Angelo | May 26, 2024 | |||
| MDD Annex V | IT-301068 | Ekuberg Pharma | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT267632 - 1 | DIS PAR | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT265149 | Global Treat | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT279840 | Global Treat | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT272175 | S&S Med Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | IT272175 | S&S Med Co.,Ltd. | May 26, 2024 | |||
| MDD Annex II Section 4 | IT279456 | Castagna Vincenzo | May 31, 2024 | |||
| MDR QMS | IT321284 | GPI S.P.A. | MDR | Feb 2023 | Feb 22, 2028 | |
| MDR QMS | IT321284 | GPI S.P.A. | MDR | Feb 2023 | Feb 22, 2028 | Issued |
| MDR QMS | IT324760 | Euleria srl Società Benefit | MDR | Jul 2023 | Jul 27, 2028 | Issued |
| MDR QMS | IT324761 | Euleria srl Società Benefit | MDR | Jul 2023 | Jul 27, 2028 | Issued |
| MDR QMS | IT324710 | Euleria srl Società Benefit | MDR | Jul 2023 | Jul 27, 2028 | Issued |
| MDR Technical Documentation | IT326645 | DEVINTEC SAGL | MDR | Sep 2024 | Sep 07, 2028 | Supplemented |
| MDR QMS | IT325651 | DEVINTEC SAGL | MDR | Sep 2024 | Sep 07, 2028 | Supplemented |
| MDR QMS | IT326369 | Biotechmed S.r.l. | MDR | Oct 2023 | Oct 17, 2028 | Issued |
| MDR QMS | IT327042 | Mercury Produzione Srl | MDR | Nov 2023 | Nov 15, 2028 | Issued |
| MDR QMS | IT328004 | FB VISION S.p.A. | MDR | Dec 2023 | Dec 19, 2028 | Issued |
| MDD Annex II (excluding section 4) | IT262561-3 | NEO VISION CO. LTD | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | IT262559-3 | NEO VISION CO. LTD | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | IT281618 | Seawon Meditech Co.,Ltd. | Dec 31, 2028 | |||
| MDD Annex II (excluding section 4) | Colex | Seawon Meditech Co.,Ltd. | Dec 31, 2028 | |||
| MDR QMS | IT328666 | SIGMA ENGINEERING S.r.l. | MDR | Jan 2024 | Jan 11, 2029 | Issued |
| MDR QMS | IT329752 | Farmasol Srl | MDR | Feb 2024 | Feb 27, 2029 | Issued |
| MDR QMS | IT331383 | FARMARES S.r.l. | MDR | Apr 2024 | Apr 15, 2029 | Issued |
| MDR QA | IT332137 | DENTAL WORLD S.R.L. | MDR | Apr 2024 | Apr 18, 2029 | Issued |
| MDR QA | IT333749 | SOGEVA Srl | MDR | Jul 2024 | Jul 08, 2029 | Issued |
| MDR QMS | IT332289 | Panin Srl | MDR | Aug 2024 | Jul 31, 2029 | Issued |
| MDR QA | IT335698 | WORK IN PROGRESS BIO-MEDICAL S.R.L. | MDR | Sep 2024 | Sep 03, 2029 | Issued |
| MDR QMS | IT335406 | Calopad AG | MDR | Sep 2024 | Sep 03, 2029 | Issued |
| MDR Technical Documentation | IT326645 | DEVINTEC SAGL | — |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| B&L Biotech | 🇰🇷 South Korea | 3 | 0 | 0 |
| DEVINTEC SAGL | 🇨🇭 Switzerland | 3 | 2 | 0 |
| Euleria srl Società Benefit | 🇮🇹 Italy | 3 | 3 | 0 |
| NEO VISION CO. LTD | 🇰🇷 South Korea | 2 | 0 | 0 |
| Akern Srl | 🇮🇹 Italy | 2 | 0 | 0 |
| ITALDEVICE S.R.L. | 🇮🇹 Italy | 2 | 0 | 0 |
| GPI S.P.A. | 🇮🇹 Italy | 2 | 2 | 0 |
| Mercury Produzione Srl | 🇮🇹 Italy | 2 | 1 | 0 |
| Woosung Medi-Filtech | 🇰🇷 South Korea | 2 | 0 | 0 |
| Seawon Meditech Co.,Ltd. | 🇰🇷 South Korea | 2 | 0 | 0 |
| Global Treat | 🇷🇴 Romania | 2 | 0 | 0 |
| S&S Med Co.,Ltd. | 🇰🇷 South Korea | 2 | 0 | 0 |
| TEHNO BIONIC SRL | 🇷🇴 Romania | 1 | 0 | 0 |
| Rossiello Angelo | 🇮🇹 Italy | 1 | 0 | 0 |
| CUREXO, INC. | 🇰🇷 South Korea | 1 | 0 | 0 |
| Ekuberg Pharma | 🇮🇹 Italy | 1 | 0 | 0 |
| DIS PAR | 🇫🇷 France | 1 | 0 | 0 |
| SECURIMED | 🇫🇷 France | 1 | 0 | 0 |
| Dexcowin | 🇰🇷 South Korea | 1 | 0 | 0 |
| E-TAKESCARE | 🇫🇷 France | 1 | 0 | 0 |
| Castagna Vincenzo | 🇮🇹 Italy | 1 | 0 | 0 |
| Coreline Soft Co., Ltd. | 🇰🇷 South Korea | 1 | 0 | 0 |
| ELITS GROUP SRL | 🇮🇹 Italy | 1 | 0 | 0 |
| AGEING TECH SRL | 🇮🇹 Italy | 1 | 0 | 0 |
| BIOPSYBELL SRL | 🇮🇹 Italy | 1 | 0 | 0 |
| Prime Color Vision Co., Ltd. | 🇰🇷 South Korea | 1 | 0 | 0 |
| Biotechmed S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| Farmasol Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| FARMARES S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| FB VISION S.p.A. | 🇮🇹 Italy | 1 | 1 | 0 |
| SIGMA ENGINEERING S.r.l. | 🇮🇹 Italy | 1 | 1 | 0 |
| DENTAL WORLD S.R.L. | 🇮🇹 Italy | 1 | 1 | 0 |
| SOGEVA Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| Panin Srl | 🇮🇹 Italy | 1 | 1 | 0 |
| Calopad AG | 🇨🇭 Switzerland | 1 | 1 | 0 |
| WORK IN PROGRESS BIO-MEDICAL S.R.L. | 🇮🇹 Italy | 1 | 1 | 0 |