Identity
- Trade Name
- Shiepz™ Anti Tandenknars EUDAMED
- Device Name
- Dental Guards EUDAMED
- Model / Reference
- 1031050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08711744053581 EUDAMED
- Basic UDI-DI
- 506001888DNTKGUARD001RS EUDAMED
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Shiepz™ Anti Tandenknars 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 (2)
- EUDAMED 07230061-b7b8-43c9-82e8-a02fb2b08ae6 61 fields · synced Jul 10, 2026
- EUDAMED 61229212-78ed-4e5f-b6c3-a46fc21328f4 61 fields · synced Jul 10, 2026