Identity
- Trade Name
- Foliodress mask EUDAMED
- Device Name
- Medical Face Masks EUDAMED
- Model / Reference
- 60000022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921865552869 EUDAMED
- Basic UDI-DI
- 69218655NJEKMFM01RY EUDAMED
- Unit of Use DI
- 16921865552866 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Foliodress mask by Jianerkang Medical 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 | 69218655NJEKMFM01RY | Class I | Active |
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Manufacturer
- Manufacturer
- Jianerkang Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011206
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 58cc4bd3-398b-402f-b01f-db102fad86ed 61 fields · synced Jul 16, 2026