Identity
- Trade Name
- Babyhaler EUDAMED
- Device Name
- Babyhaler EUDAMED
- Model / Reference
- 28003140 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 85054363000260 EUDAMED
- Basic UDI-DI
- 5054363591190289C4 EUDAMED
- EMDN Code
- R03010380 AEROSOL THERAPY SYSTEMS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Babyhaler by GlaxoSmithKline Trading Services Limited — Class I — 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 | 5054363591190289C4 | Class I | Active |
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Manufacturer
- Manufacturer
- GlaxoSmithKline Trading Services Limited
- EUDAMED SRN
- IE-MF-000008351
Sources (1)
- EUDAMED 808231fb-b9de-47e3-a242-9a93d3f63674 61 fields · synced Jun 18, 2026