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Bowie-Dick Test Pack

by Mediwish Co., Ltd 3 variants

Ref Bowie & Dick Test Pack -I 12cmx13cmx16mm BD3091Model Bowie & Dick Test Pack I; Bowie & Dick Test Pack II

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 Number697440969BDTESTSM Basic UDI-DI 06974409690220UDI-DIDate23 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  • Withdrawn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
Bowie-Dick Test Pack
Model / Reference
Bowie & Dick Test Pack I, Bowie & Dick Test Pack II, Bowie & Dick Test Pack -I 12cmx13cmx16mm BD3091
Primary DI / UDI-DI
06974409690220
Basic UDI-DI
697440969BDTESTSM
EMDN Code
S9099 Sterilisation devices (excluding cat. d - z) - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000008849
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Mediwish Co., Ltd

See all devices from Mediwish 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