Identity
- Trade Name
- Nebulizer Masks for Single Use EUDAMED
- Device Name
- Nebulizer Masks S EUDAMED
- Model / Reference
- WHQ-01-01 EUDAMEDL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970531333035 EUDAMED
- Basic UDI-DI
- 697053133nmsu2Q EUDAMED
- Direct Marketing DI
- 06970531333035 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 — 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 (1)
- EUDAMED 3b39dcda-7870-4f0e-81dc-cd3fc60cd1d1 61 fields · synced Jun 18, 2026