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Aerosol Masks
EUDAMEDClass IIa (EU MDR)
Ref HAI11-KModel nebulizer maskRef HAI14-KRef HAI11-E
Identity
- Device Name
- Aerosol Masks EUDAMED
- Model / Reference
- nebulizer mask EUDAMEDHAI11-K EUDAMEDHAI14-K EUDAMEDHAI11-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304312755 EUDAMED06970304316210 EUDAMED06970304312748 EUDAMED
- Basic UDI-DI
- 697030431220600139F EUDAMED697030431231100308N EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aerosol Masks by Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. — Class IIa — 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 | 697030431220600139F | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd.
- EUDAMED SRN
- CN-MF-000002179
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED e909bd5b-f9ab-4a59-b2af-44d560139b48 61 fields · synced Jul 9, 2026
- EUDAMED 9bc3afb8-aba3-484f-bc3d-86e833fef5c6 61 fields · synced May 17, 2026
- EUDAMED 8fee4791-46a8-4f1b-81cb-8eab66b1fb7d 61 fields · synced May 19, 2026