Identity
- Model / Reference
- MDA0000033 EUDAMEDH1008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04560264565029 EUDAMED
- Basic UDI-DI
- 45602249800000336Y EUDAMED
- Direct Marketing DI
- 04560264565036 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
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
H1008 by Nakanishi Inc. — 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 | 45602249800000336Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- EUDAMED SRN
- JP-MF-000011271
- Authorised Representative
- NSK Europe GmbH DE-AR-000007040
Sources (1)
- EUDAMED 1c903f4d-3e3d-415f-b46b-985cd9dad703 61 fields · synced Jun 18, 2026