Identity
- Trade Name
- Denka Fix Universal Handpiece Oil EUDAMED
- Device Name
- Universal Handpiece Oil EUDAMED
- Model / Reference
- D259 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060493852062 EUDAMED
- Basic UDI-DI
- 1506049385Oil8N EUDAMED
- EMDN Code
- Z12110185 INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
No
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
Denka Fix Universal Handpiece Oil by Topdental (Products) 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 | 1506049385Oil8N | Class I | Active |
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Manufacturer
- Manufacturer
- Topdental (Products) Ltd
- EUDAMED SRN
- GB-MF-000003937
- Authorised Representative
- Directa AB SE-AR-000002492
Sources (1)
- EUDAMED 0e408431-3de5-4f95-88fe-dc36daa5b5b9 61 fields · synced Aug 2, 2026