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Medical Silicone Gel Dressing

by Henan Huibo Medical Co., Ltd. 11 variants

Ref 18gModel 5g、 8g、10g、15g、18g、20g、25g、30g、40g、45g、50g

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 Number69369434MSGD001YV Basic UDI-DI 06936943400055UDI-DIDate2 Sep 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  • Withdrawn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

Model / Reference
5g、 8g、10g、15g、18g、20g、25g、30g、40g、45g、50g, 18g
Primary DI / UDI-DI
06936943400055
Basic UDI-DI
69369434MSGD001YV
EMDN Code
M04040702 Silicone dressings, combined with other substances
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CN-MF-000013580
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Henan Huibo Medical Co., Ltd.

See all devices from Henan Huibo Medical 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