Identity
- Trade Name
- NEBULISER MOUTHPIECE KIT EUDAMED
- Device Name
- Disposable Aerosol therapy EUDAMED
- Model / Reference
- XTA0082 EUDAMEDXTA0092 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980111068 EUDAMED06923980111013 EUDAMED
- Basic UDI-DI
- 69239801FD2AFKY EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Nebuliser Mouthpiece Kit by GaleMed (Xiamen) 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 | 69239801FD2AFKY | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7cf74347-bb46-485c-8d62-8f2167ed1f9e 61 fields · synced Jul 13, 2026
- EUDAMED 9ef9bc53-6a9b-45f0-9bff-bc4d4d9bea30 61 fields · synced May 19, 2026