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Hygia Splint & Hygia Belt Splint

by Woosam Medical Co., Ltd. 28 variants

Ref Hygia Belt Splint - WS-1041F

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 Number88002111EUSPLX Basic UDI-DI 138800211WS1041F029UDI-DIDate27 Nov 2024RegisteredStatusActive

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  • Withdrawn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
Hygia Splint & Hygia Belt Splint
Model / Reference
Hygia Belt Splint - WS-1041F
Primary DI / UDI-DI
138800211WS1041F029
Basic UDI-DI
88002111EUSPLX
Direct Marketing DI
138800211WS1041F029
EMDN Code
Y061219 Chest-lumb-sacral-hip-knee-ankle-foot orthoses
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
KR-MF-000045208
Authorised representative
AF Pharma Service Europe SL ES-AR-000018076

Other devices from Woosam Medical Co., Ltd.

See all devices from Woosam Medical 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