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Silicone Scar Sheet

by Hubei Decen Biotechnology Co., Ltd 4 variants

Ref customized sizeModel 1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m),customized size.

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697316144SSS01MB Basic UDI-DI 06973161441217UDI-DIDate10 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  • Withdrawn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
Silicone Scar Sheet
Model / Reference
1.6in x 40 in(4cm x 1.0m), 1.6in x 60 in(4cm x 1.5m), 1.6in x 120 in(4cm x 3m), customized size., customized size
Primary DI / UDI-DI
06973161441217
Basic UDI-DI
697316144SSS01MB
EMDN Code
M03030199 Elastic fixing bandages - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000003013
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Decen Biotechnology Co., Ltd

See all devices from Hubei Decen Biotechnology 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