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Nebulizer Masks for Single Use
EUDAMEDClass IIa (EU MDR)
Ref WHQ-01-04Model WHQ-01-01
Identity
- Trade Name
- Nebulizer Masks for Single Use EUDAMED
- Device Name
- Nebulizer Masks S EUDAMED
- Model / Reference
- WHQ-01-01 EUDAMEDWHQ-01-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531333046 EUDAMED16970531333049 EUDAMED
- Basic UDI-DI
- 697053133nmsu2Q EUDAMED
- Direct Marketing DI
- 26970531333046 EUDAMED16970531333049 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
Classification
- Device Class
- Class IIa 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
Nebulizer Masks for Single Use by Shaoxing Undis Medical Technology Co., Ltd — Class IIa — CE/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 | 697053133nmsu2Q | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 977bf38b-64ac-4c2b-9cab-ab7cbd4bbca5 61 fields · synced Oct 6, 2026
- EUDAMED 7ab8b102-87e2-4d13-85e1-6044df1c25e4 61 fields · synced May 19, 2026