Identity
- Trade Name
- Anti-fog Scope Warmer EUDAMED
- Device Name
- Anti-fog Scope Warmer EUDAMED
- Model / Reference
- 14-1640EU EUDAMED14-1642EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959221713579 EUDAMED06959221713586 EUDAMED
- Basic UDI-DI
- 69592217C001N3 EUDAMED
- EMDN Code
- Z12029011 OPTICAL HEATERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Anti-fog Scope Warmer by Premier Guard Zhongshan 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 | 69592217C001N3 | Class I | Active |
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Manufacturer
- Manufacturer
- Premier Guard Zhongshan Ltd.
- EUDAMED SRN
- CN-MF-000008071
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (2)
- EUDAMED 2108f18c-9d95-4c67-8a6f-9204b0f30dba 61 fields · synced Jul 9, 2026
- EUDAMED 775b9945-cf8f-4f11-985a-dbba200f72c4 61 fields · synced May 17, 2026