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Sterile Face Mask
EUDAMEDClass I (EU MDR)
Ref FA200-9129Model Type I, Type II, Type IIRRef FA200-9128
Identity
- Trade Name
- Sterile Face Mask EUDAMED
- Device Name
- Sterile Face Mask EUDAMED
- Model / Reference
- Type I, Type II, Type IIR EUDAMEDFA200-9129 EUDAMEDFA200-9128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991297 EUDAMED06922820991280 EUDAMED
- Basic UDI-DI
- 69228209MDN1214IS0000388T EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
Sterile Face Mask by RFX+CARE Manufacturing 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 | 69228209MDN1214IS0000388T | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED 85acd4c4-a634-43ed-b7d4-eebd41bcb44f 61 fields · synced Oct 6, 2026
- EUDAMED 0e37b3ca-ac43-40a9-80cd-a1f11ebb4df8 61 fields · synced May 19, 2026