Identity
- Trade Name
- Medical Face Mask EUDAMED
- Device Name
- Medical Face Mask EUDAMED
- Model / Reference
- FS-5222 EUDAMEDFS-5221 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942272652225 EUDAMED06942272652218 EUDAMED
- Basic UDI-DI
- 69422726P5.02.01Y5 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
Medical Face Mask by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU) — 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 | 69422726P5.02.01Y5 | Class I | Active |
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Manufacturer
- Manufacturer
- FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
- EUDAMED SRN
- CN-MF-000009645
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (2)
- EUDAMED 5bfa324a-f641-4323-9e74-fbe11d024775 61 fields · synced Oct 6, 2026
- EUDAMED 1b197034-7839-4980-b052-59f43a575df3 61 fields · synced May 18, 2026