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Non-Sterile Surgical Gown

by Allmed Medical Textile Co., Ltd (Viet Nam) 2 variants

Ref 1996.12Model Standard Style

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 Number893621715n-sterileSGownKF Basic UDI-DI 08936217151827UDI-DIDate10 Mar 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  • Withdrawn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
Non-Sterile Surgical Gown
Model / Reference
Standard Style, 1996.12
Primary DI / UDI-DI
08936217151827
Basic UDI-DI
893621715n-sterileSGownKF
EMDN Code
T020401 Standard surgical gowns
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
VN-MF-000033090
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Allmed Medical Textile Co., Ltd (Viet Nam)

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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