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Isolation Gown

by Henan JoinKona Medical Technology Co., LTD. 3 variants

Ref Conjoined

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 linked in EUDAMED

A group certificate may exist

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 Number697775109IsolationGownRF Basic UDI-DI Date26 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Conjoined
Primary DI / UDI-DI
06977751090229, 06977751090274
Basic UDI-DI
697775109IsolationGownRF, 697775109NonstisoGownY2
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000024002
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Henan JoinKona Medical Technology Co., LTD.

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Properties

  • Sterile YesEUDAMEDNoEUDAMED

Other properties (12)

  • 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