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PBT bandage PBT

by Yangzhou Super Union Import and Export Co., Ltd

Ref 15cm*5m, 7cm*5mModel 5CM,6CM,7.5CM,8CM,10CM,12CM,12.5CM,15CM,20CM, As per customer requirements

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 Number6974265590001542 Basic UDI-DI Date28 Jun 2023RegisteredStatusActive

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  • Withdrawn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
PBT bandage PBT
Model / Reference
5CM, 6CM, 7.5CM, 8CM, 10CM, 12CM, 12.5CM, 15CM, 20CM, As per customer requirements, 15cm*5m, 7cm*5m
Primary DI / UDI-DI
06974265590252, 06974265597114
Basic UDI-DI
6974265590001542
EMDN Code
M0303010101 Elastic fixing bandages, non-adhesive, extensible in one direction
Device Class
Class I
EU market of registration
Latvia

Manufacturer details

EUDAMED SRN
CN-MF-000010954
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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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