Identity
- Trade Name
- EKULF Tooth Repair Kit EUDAMED
- Device Name
- Dental Repair Kits EUDAMED
- Model / Reference
- ETP001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07392222170405 EUDAMED
- Basic UDI-DI
- 506001888DNTKREPAIR001ZN EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS 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
EKULF Tooth Repair Kit by DenTek Oral Care Limited — 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 | 506001888DNTKREPAIR001ZN | Class I | Active |
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Manufacturer
- Manufacturer
- DenTek Oral Care Limited
- EUDAMED SRN
- GB-MF-000034440
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (1)
- EUDAMED 951cefcc-61d5-470d-b753-580abf7d8c5b 61 fields · synced Jul 25, 2026