Identity
- Trade Name
- Hex Driver_ Hand Type EUDAMED
- Device Name
- Dental Surgical Instrument EUDAMED
- Model / Reference
- HDH1215S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809876905523 EUDAMED
- Basic UDI-DI
- 880927676NBRSIRSCL1S03FT EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Hex Driver_ Hand Type by Neobiotech Co., Ltd. — 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 | 880927676NBRSIRSCL1S03FT | Class I | Active |
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Manufacturer
- Manufacturer
- Neobiotech Co., Ltd.
- EUDAMED SRN
- KR-MF-000016946
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 1cf8a1eb-9c40-4e92-ba72-26b306f98841 61 fields · synced Jul 23, 2026