Identity
- Trade Name
- Maximum Protection Dental Guard EUDAMED
- Device Name
- Dental Guards EUDAMED
- Model / Reference
- 01327700101A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00047701132777 EUDAMED
- Basic UDI-DI
- 506001888DNTKGUARD001RS EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Maximum Protection Dental Guard 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 | 506001888DNTKGUARD001RS | 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 66d7877d-a9da-46f4-9c9f-96e54de3862e 61 fields · synced Jun 19, 2026