← Back to catalogue
Essentials Temporary Repair Kit 5+ (1.1g)
EUDAMEDClass I (EU MDR)
Ref 050023006DSA
Identity
- Trade Name
- Essentials Temporary Repair Kit 5+ (1.1g) EUDAMED
- Device Name
- Dental Repair Kits EUDAMED
- Model / Reference
- 050023006DSA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00047701500231 EUDAMED
- Basic UDI-DI
- 506001888DNTKREPAIR001ZN EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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
Essentials Temporary Repair Kit 5+ (1.1g) 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DenTek Oral Care Limited
- EUDAMED SRN
- GB-MF-000034440
- Authorised Representative
- Elara Pharmaservices Europe Ltd IE-AR-000011852
Sources (1)
- EUDAMED 22dd8c26-fa8c-4e52-b039-64a0f431c12d 61 fields · synced Jun 19, 2026