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Guohong

by Anhui Guohong Industrial and Trading Co., Ltd 31 variants

Ref XY055-XLModel PP Coverall, Microporous Coverall, SMS Coverall, PP+PE Laminated Coverall

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697457595coverall04EB Basic UDI-DI 06974575956021UDI-DIDate3 Dec 2022RegisteredStatusActive

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  • Withdrawn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
PP Coverall, Microporous Coverall, SMS Coverall, PP+PE Laminated Coverall, XY055-XL
Primary DI / UDI-DI
06974575956021
Basic UDI-DI
697457595coverall04EB
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000002295
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Anhui Guohong Industrial and Trading Co., Ltd

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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