Identity
- Trade Name
- Initial Drill EUDAMED
- Device Name
- Surgical Drill bits EUDAMED
- Model / Reference
- NBID2007 EUDAMEDNBID2010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809924582751 EUDAMED08809924582775 EUDAMED
- Basic UDI-DI
- 88000557DRBD EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMEDEUDAMED
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
Initial Drill by ARUM DENTISTRY Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000557DRBD | Class IIa | Unknown |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
- EUDAMED SRN
- KR-MF-000009313
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (3)
- EUDAMED 1f8ae2e2-0e2a-49be-a8f2-97e1b66bc70f 61 fields · synced Sep 30, 2026
- EUDAMED 8421785f-2dc0-4ae8-9908-9e4e9e77e097 61 fields · synced May 17, 2026
- EUDAMED 8b2ff806-4cc6-486d-9169-15a958d5a337 61 fields · synced Jul 8, 2026