Identity
- Device Name
- Night Guard EUDAMED
- Model / Reference
- 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16975586210017 EUDAMED
- Basic UDI-DI
- 697558621NightGuardEH EUDAMED
- Direct Marketing DI
- 16975586210017 EUDAMED
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS 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
Night Guard by Shenzhen Sunmc Dental Technology Co., 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 | 697558621NightGuardEH | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Sunmc Dental Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049797
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED fbef0ad2-da14-4f96-aa16-6273ad69becf 61 fields · synced Jun 19, 2026