Identity
- Device Name
- Equipment Covers EUDAMED
- Model / Reference
- 10-1104EU EUDAMED10-1104FM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06959221716228 EUDAMED
- Basic UDI-DI
- 69592217A001MM EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Equipment Covers 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 | 69592217A001MM | 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 (1)
- EUDAMED 7e2990ad-3804-4b54-8545-c7a8890e2ea7 61 fields · synced Jun 18, 2026