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Disposable gowns with elastic

by Jianli Xindi Protective Products Ltd.

Ref 161268/100, 161265/100

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 Number697724501gown20N9 Basic UDI-DI Date30 Sep 2024RegisteredStatusActive

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  • Withdrawn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

Trade Name
Disposable gowns with elastic
Disposable gowns with elastic cuffs
Device Name
Disposable Gown with elastic cuffs
Model / Reference
161268/100, 161265/100
Primary DI / UDI-DI
06977245010047, 06977245010016
Basic UDI-DI
697724501gown20N9
Direct Marketing DI
06977245010047
06977245010016
EMDN Code
T0205 Non-surgical gowns (excluding personal protective equipment - PPE)
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011449
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Jianli Xindi Protective Products 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