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Polyurethane Foam Dressing

by Hynaut Health Technology Co., LTD

Ref C163

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69259237C163NA Basic UDI-DI 06925923774507UDI-DIDate21 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
Polyurethane Foam Dressing
Model / Reference
C163
Primary DI / UDI-DI
06925923774507
Basic UDI-DI
69259237C163NA
EMDN Code
M04040601 Polyurethane dressings, non-combined
Device Class
Class I

Manufacturer details

EUDAMED SRN
CN-MF-000026762
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Hynaut Health Technology Co., LTD

See all devices from Hynaut Health Technology 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