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Wrist Splint

by e-life International Co., Ltd. 18 variants

Ref MWR0001 (XL/Right/GY), MWRFM01 (XL/Right/BG), MWR0001 (S/Right/BG), MWR0001 (L/Right/GY), MWRFM01 (S/Right/BK), MWRFM01 (L/Left/BG), MWRFM01 (XL/Left/BK), MWR0001 (M/Left/GY), MWR0001 (S/Left/BG), MWR0001 (M/Right/GY), MWRFM01 (XL/Right/BK), MWRFM01 (XS/Right/BK), MWRFM01 (M/Left/BK), MWR0001 (XL/Left/GY), MWRFM01 (S/Left/BK), MWR0001 (XL/Right/BG), MWR0001 (S/Left/GY), MWR0001 (M/Left/BG), MWRFM01 (XL/Left/BG), MWRFM01 (M/Right/BG), MWRFM01 (XS/Left/BK), MWRP801 (Youth/Left/RB)Model Wrist Brace Series

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number471230298WRSG Basic UDI-DI Date30 Apr 2026RegisteredStatusActive

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  • Withdrawn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
Wrist orthosis, hand/finger stabilizer and tubular support bandage
Model / Reference
Wrist Brace Series, MWR0001 (XL/Right/GY), MWRFM01 (XL/Right/BG), MWR0001 (S/Right/BG), MWR0001 (L/Right/GY), MWRFM01 (S/Right/BK), MWRFM01 (L/Left/BG), MWRFM01 (XL/Left/BK), MWR0001 (M/Left/GY), MWR0001 (S/Left/BG), MWR0001 (M/Right/GY), MWRFM01 (XL/Right/BK), MWRFM01 (XS/Right/BK), MWRFM01 (M/Left/BK), MWR0001 (XL/Left/GY), MWRFM01 (S/Left/BK), MWR0001 (XL/Right/BG), MWR0001 (S/Left/GY), MWR0001 (M/Left/BG), MWRFM01 (XL/Left/BG), MWRFM01 (M/Right/BG), MWRFM01 (XS/Left/BK), MWRP801 (Youth/Left/RB)
Primary DI / UDI-DI
04719894922904, 04712302983689, 04712302983368, 04719894922881, 04710374238058, 04712302983719, 04710374238485, 04719894922850, 04712302983405, 04719894922867, 04710374238492, 04719894923024, 04712302983702, 04719894922898, 04710374238089, 04712302983399, 04719894922836, 04712302983412, 04712302983726, 04712302983665, 04719894923017, 04712302988653
Basic UDI-DI
471230298WRSG
EMDN Code
Y060609 Wrist (forearm) orthoses
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TW-MF-000009901
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from e-life International Co., Ltd.

See all devices from e-life International 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