Identity
- Trade Name
- GALENA EUDAMED
- Device Name
- Alternating air mattress with pump EUDAMED
- Model / Reference
- XT-50 EUDAMEDGS-200 EUDAMEDXT-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6971066420740 EUDAMED6971066420733 EUDAMED6971066420726 EUDAMED
- Basic UDI-DI
- 697106642XT-50H7 EUDAMED697106642GS-2008C EUDAMED697106642XT-40H4 EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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 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 | 697106642XT-50H7 | Class I | 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 (3)
- EUDAMED 7eef66f1-37d1-4632-83d5-4ea9a429f9df 61 fields · synced Aug 3, 2026
- EUDAMED b2e7d2e0-1336-48dd-a6b5-090347218903 61 fields · synced May 18, 2026
- EUDAMED bc088696-0fac-4ce1-9988-2e837104da7a 61 fields · synced May 18, 2026