Identity
- Trade Name
- i-RANGE i-LUBE Universal Handpiece Oil EUDAMED
- Device Name
- Universal Handpiece Oil EUDAMED
- Model / Reference
- ILUB500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060493851683 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
i-RANGE i-LUBE 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 d029decd-4cff-49e8-8275-91120136946f 61 fields · synced Jun 18, 2026