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Welllead Mesh Nebulizer Kit
EUDAMEDClass IIa (EU MDR)
Ref R01L023130Model AeroTank Kit
Identity
- Trade Name
- Welllead Mesh Nebulizer Kit EUDAMED
- Device Name
- Mesh Nebulizer Kit EUDAMED
- Model / Reference
- AeroTank Kit EUDAMEDR01L023130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06925816649462 EUDAMED
- Basic UDI-DI
- 69449327FR01E04KP EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Welllead Mesh Nebulizer Kit by Well Lead Medical 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 | 69449327FR01E04KP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000006728
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 701789d6-8570-4f43-b77a-032fe34e4108 61 fields · synced Jul 24, 2026