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Disposable tray

by Wellmien Healthcare Tech. (Suzhou) Co., Ltd. 2 variants

Ref 500mlModel 700ml, 500ml(As customized)

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697457045DT001G7 Basic UDI-DI 06974570451125UDI-DIDate17 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  • Withdrawn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

Model / Reference
700ml, 500ml(As customized), 500ml
Primary DI / UDI-DI
06974570451125
Basic UDI-DI
697457045DT001G7
EMDN Code
V9099 Various devices not included in other classes - other
Device Class
Class I
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010365
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Wellmien Healthcare Tech. (Suzhou) Co., Ltd.

See all devices from Wellmien Healthcare Tech. (Suzhou) 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