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Isolation gown

by Hubei Hope medical devices co., ltd 3 variants

Ref 110*122cm, 115x137cm, 135*156cm, 140*160cm, 130x150cm, 112x125cm, 115x130cmModel XS S M L XL XXL XXXL XXXXL Universal Size

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 Number697605962IS001JU Basic UDI-DI Date12 Jul 2023RegisteredStatusActive

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  • Withdrawn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
Isolation gown
Model / Reference
XS S M L XL XXL XXXL XXXXL Universal Size, 110*122cm, 115x137cm, 135*156cm, 140*160cm, 130x150cm, 112x125cm, 115x130cm
Primary DI / UDI-DI
06976059620091, 06976059620121, 06976059620152, 06976059620060, 06976059620039, 06976059620169, 06976059620053, 06976059620107, 06976059620114, 06976059620015, 06976059620145, 06976059620077, 06976059620008, 06976059620022
Basic UDI-DI
697605962IS001JU
Direct Marketing DI
06976059620091
06976059620121
06976059620152
06976059620060
06976059620039
06976059620169
06976059620053
06976059620107
06976059620114
06976059620015
06976059620145
06976059620077
06976059620008
06976059620022
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000028313
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Hope medical devices 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