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Nonwoven Isolation Gown

by Shanghai Sunshore Medical Instruments Co., Ltd EUDAMED

Active European Union

Ref 110x137cmModel 110x137cm,110x140cm, 110x147cm, 115x137cm, 120x140cm,120x150cm,125x145cm,125x150cm,130x150cm,130x160cm,135x155cm, XS/S/M/L/XL/XXL/XXXL ; 16g,18g,20g,25g, etc.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number698023123NIG00183 Basic UDI-DIDate6 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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
Nonwoven Isolation Gown
Model / Reference
110x137cm, 110x140cm, 110x147cm, 115x137cm, 120x140cm, 120x150cm, 125x145cm, 125x150cm, 130x150cm, 130x160cm, 135x155cm, XS/S/M/L/XL/XXL/XXXL, 16g, 18g, 20g, 25g, etc.
Primary DI / UDI-DI
06980231233962
Basic UDI-DI
698023123NIG00183
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000056183
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shanghai Sunshore Medical Instruments Co., Ltd

See all devices from Shanghai Sunshore Medical Instruments 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