Identity
- Model / Reference
- Night Guard EUDAMED000869002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 5060143577659 EUDAMED
- Basic UDI-DI
- 506014357NightGuardB8 EUDAMED
- Direct Marketing DI
- 5060143577659 EUDAMED
- EMDN Code
- Q01010399 DENTAL MEDICATION DEVICES - OTHER 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
000869002 by OPRO International Ltd — 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 | 506014357NightGuardB8 | Class I | Active |
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Manufacturer
- Manufacturer
- OPRO International Ltd
- EUDAMED SRN
- GB-MF-000004793
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED d50c9ea8-fbe2-484c-baad-162d381935d0 61 fields · synced Jun 18, 2026