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Hydrocolloid Dressings

by Dongguan Samvo Biotechnology Co., Ltd. 10 variants

Ref SM5010Model SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050

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 Number697991980HCDZK Basic UDI-DI 06979919800060UDI-DIDate20 Mar 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  • Withdrawn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

Model / Reference
SM40L SM36L SM51L SM52L SM45L SM5010 SM5015 SM5020 SM5030 SM5050, SM5010
Primary DI / UDI-DI
06979919800060
Basic UDI-DI
697991980HCDZK
EMDN Code
M04040301 Hydrocolloid dressings, non-combined
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052566
Authorised representative
HyperCert Limited B.V. NL-AR-000047746

Other devices from Dongguan Samvo Biotechnology Co., Ltd.

See all devices from Dongguan Samvo 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