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isolation gown

by Shanghai Jolly Industrial Co., Ltd. EUDAMED

Active European Union

Ref SHIG01Model SHIG01, SHIG02, SHIG03, SHIG04, SHIG05, SHIG06, SHIG07, SHIG08, SHIG09, SHIG10, SHIG11, SHIG12, SHIG13, SHIG14, SHIG15, SHIG16, SHIG17, SHIG18, SHIG19, SHIG20

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697992613isolationgown6A Basic UDI-DIDate17 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
isolation gown
Model / Reference
SHIG01, SHIG02, SHIG03, SHIG04, SHIG05, SHIG06, SHIG07, SHIG08, SHIG09, SHIG10, SHIG11, SHIG12, SHIG13, SHIG14, SHIG15, SHIG16, SHIG17, SHIG18, SHIG19, SHIG20
Primary DI / UDI-DI
06979926131003
Basic UDI-DI
697992613isolationgown6A
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052500
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Jolly Industrial Co., Ltd.

See all devices from Shanghai Jolly Industrial 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