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Disposable Surgical Gown

by Raysen (Tianjin) Healthcare Products Co., Ltd China EUDAMED

Ref MDR EMDN T020401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697292060SG001FM Basic UDI-DIDate1 Dec 2023RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Device Name
Disposable Surgical Gown
Model / Reference
MDR
Primary DI / UDI-DI
06972920601480, 06972920602586
Basic UDI-DI
697292060SG001FM
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
Market of Registration
Germany
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000003242
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Raysen (Tianjin) Healthcare Products Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • 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

Sources (2)

  • EUDAMED 65e14275-df20-4f2a-ac45-33f50e5a63a9 61 fields · synced 22 Oct 2026
  • EUDAMED 06972920602586|697292060SG001FM 61 fields · synced 17 May 2026