Identity
- Trade Name
- Abutment Handle EUDAMED
- Device Name
- Dental Implant System Components EUDAMED
- Model / Reference
- S-HDL45 EUDAMEDS-AH EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188201925 EUDAMED07630188214543 EUDAMED
- Basic UDI-DI
- 763018820003BX EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Abutment Handle by Novodent SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 763018820003BX | Class I | Active |
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Manufacturer
- Manufacturer
- Novodent SA
- EUDAMED SRN
- CH-MF-000023309
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED bb454d9b-68dd-40e2-99c5-57fd30cfa748 61 fields · synced Jul 10, 2026
- EUDAMED 359eb5f8-a1ac-4caa-af73-f9eb8ba4ee71 61 fields · synced May 18, 2026