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Self-adhesive Bandage

by Yangzhou Ponte Medical Technology Co.

Ref 2cm*2mModel 2cm*2m,2cm*4m,2cm*4.5m,2cm*5m,2cm*6.9m,2cm*9.1m,2cm*13.7m, 2.5cm*2m,2.5cm*4m,2.5cm*4.5m,2.5cm*5m,2.5cm*6.9m,2.5cm*9.1m,2.5cm*13.7m, 3cm*2m,3cm*4m,3cm*4.5m,3cm*5m,3cm*6.9m, etc

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 Number697898052SAB001S3 Basic UDI-DI 06978980520013UDI-DIDate13 Aug 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  • Withdrawn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
Self-adhesive Bandage
Model / Reference
2cm*2m, 2cm*4m, 2cm*4.5m, 2cm*5m, 2cm*6.9m, 2cm*9.1m, 2cm*13.7m, 2.5cm*2m, 2.5cm*4m, 2.5cm*4.5m, 2.5cm*5m, 2.5cm*6.9m, 2.5cm*9.1m, 2.5cm*13.7m, 3cm*2m, 3cm*4m, 3cm*4.5m, 3cm*5m, 3cm*6.9m, etc
Primary DI / UDI-DI
06978980520013
Basic UDI-DI
697898052SAB001S3
EMDN Code
M0303010201 Elastic fixing bandages, self-adhesive, extensible in one direction
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000048649
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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