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Mono Implant Regular Rough
EUDAMEDClass IIb (EU MDR)
Ref MR4112-B
by Novodent SA
Identity
- Trade Name
- Mono Implant Regular Rough EUDAMED
- Device Name
- Mono Implant Regular Rough EUDAMED
- Model / Reference
- MR4112-B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640168189853 EUDAMED
- Basic UDI-DI
- B-07640168189853 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mono Implant Regular Rough by Novodent SA — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-07640168189853 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 52a3b12a-349a-412c-a0f8-63a6149893d4 61 fields · synced Jun 19, 2026