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Temparin Max Repair Kit 24+ (2 x 2.64g)
EUDAMEDClass I (EU MDR)
Ref 05032100101A
Identity
- Trade Name
- Temparin Max Repair Kit 24+ (2 x 2.64g) EUDAMED
- Device Name
- Dental Repair Kits EUDAMED
- Model / Reference
- 05032100101A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00047701503218 EUDAMED
- Basic UDI-DI
- 506001888DNTKREPAIR001ZN EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- 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
Temparin Max Repair Kit 24+ (2 x 2.64g) 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 18c44256-85fc-43c8-af38-bab8920e19aa 61 fields · synced Jul 11, 2026