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Alternating Pressure Mattress
EUDAMEDClass I (EU MDR)
Ref EFFECT400Model EFFECE250 EFFECT250F EFFECT250V EFFECT250VF EFFECT350 EFFECT400 EFFECT500 EFFECT520 EFFECT540 EFFECT560 EFFECT820 EFFECT840 EFFECT860 EFFECT960
Identity
- Trade Name
- Alternating Pressure Mattress EUDAMED
- Device Name
- Alternating Pressure Mattress EUDAMED
- Model / Reference
- EFFECE250 EFFECT250F EFFECT250V EFFECT250VF EFFECT350 EFFECT400 EFFECT500 EFFECT520 EFFECT540 EFFECT560 EFFECT820 EFFECT840 EFFECT860 EFFECT960 EUDAMEDEFFECT400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06979080640069 EUDAMED
- Basic UDI-DI
- 697908064SBHMSP EUDAMED
- EMDN Code
- V080701 ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Alternating Pressure Mattress by ShengBaiHui (Zhangzhou) Medical Technology 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 | 697908064SBHMSP | Class I | Active |
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Manufacturer
- Manufacturer
- ShengBaiHui (Zhangzhou) Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000049081
- Authorised Representative
- HyperCert Limited B.V. NL-AR-000047746
Sources (1)
- EUDAMED 1b762948-c573-45cb-9725-c2af18f1d895 61 fields · synced Jun 19, 2026