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Conwell

by Conwell Medical Co., Ltd. 448 variants

Ref 5309 ROM Elbow Brace (L/XL)Model 5301, 53020, 53030, 5304, 5305, 53070, 5308, 5309, 53100, 53110, 53120, 5313, 5314, 5315, 53160, 5319, 53200, 53210, 53220, 5325, 5326, 53270, 53280, 5329, 53300, 53350, 53400, 5345

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 Number471987893WRIST-53000W6 Basic UDI-DI 04719878932288UDI-DIDate26 Mar 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Device Name
Soft Support, Brace, Orthosis (Wrist series)
Model / Reference
5301, 53020, 53030, 5304, 5305, 53070, 5308, 5309, 53100, 53110, 53120, 5313, 5314, 5315, 53160, 5319, 53200, 53210, 53220, 5325, 5326, 53270, 53280, 5329, 53300, 53350, 53400, 5345, 5309 ROM Elbow Brace (L/XL)
Primary DI / UDI-DI
04719878932288
Basic UDI-DI
471987893WRIST-53000W6
EMDN Code
Y060603, Y060609, Y060612, Y060615
Device Class
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000012101
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Conwell Medical Co., Ltd.

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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