Identity
- Trade Name
- HD Diamond Coated Dental Burs EUDAMED
- Device Name
- Non-Sterile Diamond Coated Dental Burs EUDAMED
- Model / Reference
- 429812-44-39 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 47291081551104 EUDAMED
- Basic UDI-DI
- 7291081DiamondnonStrlQP EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HD Diamond Coated Dental Burs by Hasharon Dental Center Ltd. — Class IIa — 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 | 7291081DiamondnonStrlQP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hasharon Dental Center Ltd.
- EUDAMED SRN
- IL-MF-000011308
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 9d8ce421-3051-4421-8f25-4e63c2a5980a 61 fields · synced Jun 18, 2026