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Bedsore Prevention Mattress
EUDAMEDClass I (EU MDR)
Ref B01Model B01, B02, B03, B04, B04-1
Identity
- Device Name
- Bedsore Prevention Mattress EUDAMED
- Model / Reference
- B01, B02, B03, B04, B04-1 EUDAMEDB01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978143211505 EUDAMED
- Basic UDI-DI
- 697814321BPM01G7 EUDAMED
- EMDN Code
- V08068002 BED SUPPORTS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Bedsore Prevention Mattress by Hebei inheritance Xiaoai Medical Equipment 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 | 697814321BPM01G7 | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei inheritance Xiaoai Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000020633
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 6d59c3e7-3f8a-4dbc-8ee3-e3407eaddc06 61 fields · synced Oct 5, 2026