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Isolation Gown

by Hubei Feiteng Protective Products Co., Ltd. EUDAMED

Active European Union

Ref 115*165Model 105*120cm 130*160cm 110*130 115*137 120*140 125*145 130*150 135*155 140*160

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697365635FTIGRS Basic UDI-DIDate11 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Isolation Gown
Model / Reference
105*120cm 130*160cm 110*130 115*137 120*140 125*145 130*150 135*155 140*160, 115*165
Primary DI / UDI-DI
06973656350536
Basic UDI-DI
697365635FTIGRS
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Slovakia

Manufacturer details

EUDAMED SRN
CN-MF-000004538
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hubei Feiteng Protective Products 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