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Spaderm

by Hangzhou Gspmed Medical Appliances Co., Ltd. 2 variants

Ref ZHEHANGXIEBEI20180566Model Wrinkle

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69313467FKT002JT Basic UDI-DI 06931346750349UDI-DIDate27 Jun 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  • Withdrawn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
Wrinkle tape
Model / Reference
Wrinkle, ZHEHANGXIEBEI20180566
Primary DI / UDI-DI
06931346750349
Basic UDI-DI
69313467FKT002JT
Direct Marketing DI
06931346750349
EMDN Code
M030402030102 Elastic support bandages, adhesive extensible in one direction, high extensibility
Device Class
Class I
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000018891
Authorised representative
Prolinx GmbH DE-AR-000005129

Other devices from Hangzhou GspMed Medical Appliances Co., Ltd.

See all devices from Hangzhou GspMed Medical Appliances 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