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FWS-WJ-008C Ballon cover

by Chongqing FWS Medical Device Co., Ltd

Model FWS-WJ-008C Ballon cover (sterile)

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-008C/BC2X Basic UDI-DI D-008C/BC2XUDI-DIDate13 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Device Name
Vertebroplasty auxiliary instrument
Model / Reference
FWS-WJ-008C Ballon cover (sterile)
Primary DI / UDI-DI
D-008C/BC2X
Basic UDI-DI
B-008C/BC2X
EMDN Code
P099002 Orthopaedic cement preparation and application devices and kits
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000008972
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Chongqing FWS Medical Device Co., Ltd

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No