Skip to content

Disposable Surgical Gown

by Sanqi (Vietnam) New Materials Co., Ltd.

Ref SQ-G5001-XXLModel SQ-G5001 (XXL, XL, L, M, S) SQ-G6001 (XXL, XL, L, M, S)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8938532565DSGM3 Basic UDI-DI 08938532565495UDI-DIDate28 Jul 2026RegisteredStatusActive

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  • Withdrawn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
Disposable Surgical Gown
Model / Reference
SQ-G5001 (XXL, XL, L, M, S) SQ-G6001 (XXL, S), SQ-G5001-XXL
Primary DI / UDI-DI
08938532565495
Basic UDI-DI
8938532565DSGM3
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
VN-MF-000008919
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Sanqi (Vietnam) New Materials 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