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hand &wrist brace

by Shandong Esp Healthcare Co., Ltd.

Ref ZRWA23Model ZRWA23, ZRWA24, ZRWA24B, ZRWA24C, ZRWA24D, ZRWA25, ZRWA25F, Wrist001, Wrist002, Wrist003, ZRWA32, ZRWM10, ZRWM11, CTB01, GLOVE01, GLOVE02, GLOVE04, GLOVE05, MG01

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 Number697826271BD05KG Basic UDI-DI 06978262712310UDI-DIDate23 Apr 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  • Withdrawn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
hand &wrist brace
Model / Reference
ZRWA23, ZRWA24, ZRWA24B, ZRWA24C, ZRWA24D, ZRWA25, ZRWA25F, Wrist001, Wrist002, Wrist003, ZRWA32, ZRWM10, ZRWM11, CTB01, GLOVE01, GLOVE02, GLOVE04, GLOVE05, MG01
Primary DI / UDI-DI
06978262712310
Basic UDI-DI
697826271BD05KG
EMDN Code
Y090699 Devices for body protection - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000046165
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shandong Esp Healthcare 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