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Acoustic Isolation Membrane

by Hynaut Health Technology Co., LTD

Ref C322

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 Number69702374C322L3 Basic UDI-DI 06970016563537UDI-DIDate22 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  • Withdrawn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
Sound-permeable Membrane
Model / Reference
C322
Primary DI / UDI-DI
06970016563537
Basic UDI-DI
69702374C322L3
EMDN Code
U1299 Single-use urogenital instrumentation (non-endoscopic) - other
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