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Sterile Container

by Enlightening Pallet Industry Co., Limited

Ref 0.1ML, 60MLModel 60ml

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/IVDD NumberB-06977731460004 Basic UDI-DI Date13 Aug 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Sterile Container
Model / Reference
0.1ML, 60ml
Primary DI / UDI-DI
06977731460004, 06977731460264
Basic UDI-DI
B-06977731460004, B-06977731460264
EMDN Code
W05010203 Urine collection, containers
Device Class
Class IVD General
EU market of registration
Austria
France

Manufacturer details

EUDAMED SRN
CN-MF-000043508
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Properties

  • Sterile
  • Professional Testing

Other properties (8)

  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No