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Nebulizer Masks for Single Use
EUDAMEDClass IIa (EU MDR)
Ref WHQ-02-01Model WHQ-01-01
Identity
- Trade Name
- Nebulizer Masks for Single Use EUDAMED
- Device Name
- Nebulizer Masks S EUDAMED
- Model / Reference
- WHQ-01-01 EUDAMEDWHQ-02-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531333053 EUDAMED16970531333056 EUDAMED
- Basic UDI-DI
- 697053133nmsu2Q EUDAMED
- Direct Marketing DI
- 26970531333053 EUDAMED16970531333056 EUDAMED
- EMDN Code
- R0680 NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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 4a476d59-59d0-4301-92b8-aabeb45ad7d1 61 fields · synced Oct 6, 2026
- EUDAMED 486501c5-92b3-4fe1-8da6-d4c56289db18 61 fields · synced May 19, 2026