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Nebulizer Masks for Single Use
EUDAMEDClass IIa (EU MDR)
Ref MModel WHQ-01-01Ref WHQ-02-01Ref WHQ-01-03Ref SRef WHQ-02-02Ref WHQ-01-04
Identity
- Trade Name
- Nebulizer Masks for Single Use EUDAMED
- Device Name
- Nebulizer Masks S EUDAMED
- Model / Reference
- WHQ-01-01 EUDAMEDM EUDAMEDWHQ-02-01 EUDAMEDWHQ-01-03 EUDAMEDS EUDAMEDWHQ-02-02 EUDAMEDWHQ-01-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26970531333022 EUDAMED16970531333025 EUDAMED06970531333028 EUDAMED26970531333053 EUDAMED26970531333039 EUDAMED26970531333015 EUDAMED06970531333011 EUDAMED16970531333056 EUDAMED16970531333063 EUDAMED26970531333046 EUDAMED16970531333049 EUDAMED
- Basic UDI-DI
- 697053133nmsu2Q EUDAMED
- Direct Marketing DI
- 26970531333022 EUDAMED16970531333025 EUDAMED06970531333028 EUDAMED26970531333053 EUDAMED26970531333039 EUDAMED26970531333015 EUDAMED06970531333011 EUDAMED16970531333056 EUDAMED16970531333063 EUDAMED26970531333046 EUDAMED16970531333049 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMEDR0680 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 — 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 (11)
- EUDAMED 43d921b6-e030-472c-9a96-902cf224dd0a 61 fields · synced Jul 29, 2026
- EUDAMED 222ffab1-1eea-4c6a-8360-571e9c6ae84b 61 fields · synced May 16, 2026
- EUDAMED bb6bae91-9b3d-4a93-83d5-74ea2a504732 61 fields · synced May 16, 2026
- EUDAMED 4a476d59-59d0-4301-92b8-aabeb45ad7d1 61 fields · synced May 16, 2026
- EUDAMED e23378b0-4ee5-49d0-a8d3-85d7313a535c 61 fields · synced May 17, 2026
- EUDAMED f4690361-a9fc-4dc2-a20e-a63fa41fa74e 61 fields · synced May 18, 2026
- EUDAMED 626a578a-e625-433e-808f-5972aaeed1a5 61 fields · synced May 18, 2026
- EUDAMED 486501c5-92b3-4fe1-8da6-d4c56289db18 61 fields · synced May 19, 2026
- EUDAMED 78b2c1ce-e70a-4cc7-8982-b38550efecc7 61 fields · synced May 19, 2026
- EUDAMED 977bf38b-64ac-4c2b-9cab-ab7cbd4bbca5 61 fields · synced May 19, 2026
- EUDAMED 7ab8b102-87e2-4d13-85e1-6044df1c25e4 61 fields · synced May 19, 2026