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nebulizer mask-s
EUDAMEDClass IIa (EU MDR)
Ref HAI14-EModel nebulizer maskRef HAI12-ERef HAI12-KRef HAI13-KRef HAI13-E
Identity
- Trade Name
- nebulizer mask-s EUDAMEDnebulizer EUDAMEDnebulizer mask EUDAMED
- Device Name
- Aerosol Masks EUDAMED
- Model / Reference
- nebulizer mask EUDAMEDHAI14-E EUDAMEDHAI12-E EUDAMEDHAI12-K EUDAMEDHAI13-K EUDAMEDHAI13-E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970304316203 EUDAMED06970304316074 EUDAMED06970304316081 EUDAMED06970304312779 EUDAMED06970304312762 EUDAMED
- Basic UDI-DI
- 697030431231100308N EUDAMED697030431220600139F EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
nebulizer mask-s 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 | 697030431231100308N | 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 (5)
- EUDAMED 6c34876f-7663-4c54-9af7-051a7f87ec5c 61 fields · synced Sep 17, 2026
- EUDAMED 2735a999-fda4-498f-81a9-d1932e7f662c 61 fields · synced May 17, 2026
- EUDAMED 1f2a7fc2-ae58-4f19-ad0f-9eb34df69171 61 fields · synced May 17, 2026
- EUDAMED 0f29a7f4-1f28-4206-b484-6d0304849827 61 fields · synced May 18, 2026
- EUDAMED f117f9b1-d355-4d7f-b43b-01cc989ef75a 61 fields · synced May 18, 2026