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Bone Level Aggressive Reamer Drill
EUDAMEDClass IIa (EU MDR)
Ref S-BARD4.5
by Novodent SA
Identity
- Trade Name
- Bone Level Aggressive Reamer Drill EUDAMED
- Device Name
- Bone Level Aggressive Reamer Drill EUDAMED
- Model / Reference
- S-BARD4.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07630188206616 EUDAMED
- Basic UDI-DI
- B-07630188206616 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bone Level Aggressive Reamer Drill by Novodent SA — Class IIa — 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-07630188206616 | Class IIa | 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 33ef5961-0412-4c53-83f6-be7427bae095 61 fields · synced Jun 19, 2026