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Non-woven Face Mask
EUDAMEDClass I (EU MDR)
Ref Ear-loopModel Ear-loop, Strap-on(Tie-on)
Identity
- Device Name
- Non-woven Face Mask EUDAMED
- Model / Reference
- Ear-loop, Strap-on(Tie-on) EUDAMEDEar-loop EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16973141150105 EUDAMED
- Basic UDI-DI
- 697314115F90000VA EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Non-woven Face Mask by Hubei Haixin Protective Products Group 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 | 697314115F90000VA | Class I | Active |
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Manufacturer
- Manufacturer
- Hubei Haixin Protective Products Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000026316
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 21a64788-d7a6-4bfd-85e8-54a9a0dcc81c 61 fields · synced Aug 4, 2026