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Spengler TB100

by Tyson Bioresearch, Inc. 3 variants

Ref 745010Model Spengler TB100

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-T05D5710003ANJ6 Basic UDI-DI D-T05D5710003ANJ6UDI-DIDate23 Sep 2022RegisteredStatusActive

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  • Withdrawn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
Spengler TB100 Blood Glucose Test Strips
Model / Reference
Spengler TB100, 745010
Primary DI / UDI-DI
D-T05D5710003ANJ6
Basic UDI-DI
B-T05D5710003ANJ6
EMDN Code
W0101060101 Glucose test strips
Device Class
Class IVD Annex II List B
EU market of registration
France

Manufacturer details

EUDAMED SRN
TW-MF-000027508
Authorised representative
MDSS GmbH DE-AR-000005430

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Properties

  • Reagent
  • Self Testing
  • Professional Testing

Other properties (7)

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