Identity
- Trade Name
- PAEDIATRIC AEROSOL MASK EUDAMEDPaediatric aerosol mask - with tubing EUDAMED
- Device Name
- Disposable Mask EUDAMEDDisposable Aerosol therapy EUDAMED
- Model / Reference
- XTA0074 EUDAMEDXTA0091 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980109720 EUDAMED06923980111020 EUDAMED
- Basic UDI-DI
- 69239801ND2KAPC EUDAMED69239801FD2ADKU EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMEDR03010304 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Paediatric Aerosol Mask 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 | 69239801ND2KAPC | 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 c5053613-1138-4268-a908-772141d55e7b 61 fields · synced Jul 9, 2026
- EUDAMED 82965f0b-6db1-4cac-ad29-6797adb2f123 61 fields · synced May 16, 2026