Identity
- Trade Name
- Neb.Easy AM-1 Mask, Infant w/Tube EUDAMED
- Device Name
- Disposable Aerosol therapy EUDAMED
- Model / Reference
- AD0053 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980103681 EUDAMED
- Basic UDI-DI
- 69239801FD2ACKS EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
Neb.Easy AM-1 Mask, Infant w/Tube 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 | 69239801FD2ACKS | 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 (1)
- EUDAMED 2f20ef1d-aab6-4f0f-9956-5f0edc02533f 61 fields · synced Jul 21, 2026