Identity
- Trade Name
- GALENA EUDAMED
- Device Name
- COMPRESSOR NEBULIZER EUDAMED
- Model / Reference
- BC-68002 EUDAMEDBC68002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6971066420498 EUDAMED
- Basic UDI-DI
- 697106642BC680022W EUDAMED
- EMDN Code
- R060203 INHALATION THERAPY HUMIDIFICATION LIQUIDS 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
Galena by Foshan Hongfeng 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 | 697106642BC680022W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foshan Hongfeng Co. Ltd.
- EUDAMED SRN
- CN-MF-000016042
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 3d8144ad-07f2-453d-836a-43ec018b3c8f 61 fields · synced Jun 19, 2026