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Disposable Isolation Gown

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

Active European Union

Ref SQ-I1001-XXLModel SQ-I1001 (XXL, XL, L, M, S); SQ-I2001 (XXL, XL, L, M, S); SQ-I3001 (XXL, XL, L, M, S); SQ-I4001 (XXL, XL, L, M, S)

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8938532565DIGL5 Basic UDI-DIDate28 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  • Withdrawn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
Disposable Isolation Gown
Model / Reference
SQ-I1001 (XXL, XL, L, M, S), SQ-I2001 (XXL, SQ-I3001 (XXL, SQ-I4001 (XXL, SQ-I1001-XXL
Primary DI / UDI-DI
08938532565341
Basic UDI-DI
8938532565DIGL5
EMDN Code
T0299 Protection drapes and garments - other
Device Class
Class I
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