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Medical Anti - bedsore Cushion

by Hebei Boxin Recovery Equipment CO., LTD 5 variants

Ref BX-P05Model BX-P01,BX-P02,BX-P03,BX-P04,BX-P05

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697140822MABC01A8 Basic UDI-DI 06971408228447UDI-DIDate21 Oct 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Medical Anti - bedsore Cushion
Model / Reference
BX-P01, BX-P02, BX-P03, BX-P04, BX-P05
Primary DI / UDI-DI
06971408228447
Basic UDI-DI
697140822MABC01A8
EMDN Code
V080701 Active anti-decubitus medical mattresses
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046611
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hebei Boxin Recovery Equipment CO., LTD

See all devices from Hebei Boxin Recovery Equipment CO., LTD →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No