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Disposable Medical Mask Type IIR
EUDAMEDClass I (EU MDR)
Ref F005Model 17.5cm*9.5cm
Identity
- Trade Name
- Disposable Medical Mask Type IIR EUDAMED
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- 17.5cm*9.5cm EUDAMEDF005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938056233599 EUDAMED
- Basic UDI-DI
- 69380562mask0001HD EUDAMED
- Unit of Use DI
- 86938056233595 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece 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
Disposable Medical Mask Type IIR by Zhejiang Hongyu Medical Commodity 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 | 69380562mask0001HD | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Hongyu Medical Commodity Co., Ltd
- EUDAMED SRN
- CN-MF-000008204
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a0b156d5-f2ce-49ec-892a-5b5a3decaa1e 61 fields · synced Oct 6, 2026