Identity
- Trade Name
- HD Diamond Coated Dental Burs EUDAMED
- Device Name
- Sterile Diamond Coated Dental Burs EUDAMED
- Model / Reference
- 119918-43-6D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 67291081039583 EUDAMED
- Basic UDI-DI
- 7291081DiamondSterileEW EUDAMED
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Category: Carbide dental bur, single-use
HD Diamond Coated Dental Burs by Hasharon Dental Center Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 7291081DiamondSterileEW | 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 c1e4e1b5-4fc6-44a3-a0d5-6e3ae8bf6c76 61 fields · synced Jun 17, 2026