Notified Body
NB 1282
🇮🇹 Italy
ENTE CERTIFICAZIONE MACCHINE SRL
Via Ca’ Bella, 243/A - loc. Castello di Serravalle, 40053 Valsamoggia (BO), Italy
View on EUDAMED
Updated Oct 15, 2022
Certificates
13
Valid
0
Expiring < 6mo
0
Expired
10
Basic UDI-DIs
373
Devices
373
Manufacturers
9
Cert. Types
2
Basic Information
- Address
- Via Ca’ Bella, 243/A - loc. Castello di Serravalle, 40053 Valsamoggia (BO), Italy
- [email protected]
- Phone
- +39 051 6705141
- Website
- www.entecerma.it
Regulatory Overview
Regulation
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Eu Mdd
373
Classification
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Eu Md Class 2b
335
Eu Md Class 2a
38
Device Types
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Certificate Health
Total
13
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
10
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | ECM18MDD001 | Engineering Production Equipment Medical Srl | Feb 12, 2022 | |||
| MDD Annex V | ECM20MDD004 | Morpheus AG | May 26, 2023 | |||
| MDD Annex V | ECM20MDD004 | Morpheus AG | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | ECM21MDD003 | DEBx Medical BV | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | ECM21MDD003 | DEBx Medical BV | May 27, 2024 | |||
| MDD Annex V | ECM19MDD004 | Pivotal Health Solutions | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | ECM19MDD013 | Laboratoires I2M | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | ECM20MDD022 | A.M.I. Italia s.r.l. | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | ECM20MDD021 | Scholten Surgical Instruments, Inc. | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | ECM20MDD003 | Cambridge Interventional LLC | May 27, 2024 | |||
| MDD Annex V | 301081783 | President Dental GmbH | Dec 31, 2028 | |||
| MDD Annex V | M.2020.106.13803 | President Dental GmbH | Dec 31, 2028 | |||
| MDD Annex V | 301081783 | President Dental GmbH | Dec 31, 2028 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| President Dental GmbH | 🇩🇪 Germany | 3 | 0 | 0 |
| DEBx Medical BV | 🇳🇱 Netherlands | 2 | 0 | 0 |
| Morpheus AG | 🇩🇪 Germany | 2 | 0 | 0 |
| Pivotal Health Solutions | 🇺🇸 United States | 1 | 0 | 0 |
| Laboratoires I2M | 🇫🇷 France | 1 | 0 | 0 |
| A.M.I. Italia s.r.l. | 🇮🇹 Italy | 1 | 0 | 0 |
| Scholten Surgical Instruments, Inc. | 🇺🇸 United States | 1 | 0 | 0 |
| Cambridge Interventional LLC | 🇺🇸 United States | 1 | 0 | 0 |
| Engineering Production Equipment Medical Srl | 🇮🇹 Italy | 1 | 0 | 0 |