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Rossmax

by Tyson Bioresearch, Inc. 5 variants

Ref BGM_KIT_002_RMModel Rossmax HS200

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-T05H1690071KNQQ Basic UDI-DI Date27 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  • Withdrawn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
Rossmax HS200 Blood Glucose Monitoring System
Model / Reference
Rossmax HS200, BGM_KIT_002_RM
Primary DI / UDI-DI
D-T05H1690071KNQQ, D-T05H1690040KNPW
Basic UDI-DI
B-T05H1690071KNQQ, B-T05H1690040KNPW
EMDN Code
W0201060102 Blood glucose meters
Device Class
Class IVD Annex II List B
EU market of registration
Belgium

Manufacturer details

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

Other devices from Tyson Bioresearch, Inc.

See all devices from Tyson Bioresearch, Inc. →

Properties

  • Reagent
  • Self Testing
  • Professional Testing
  • Surgical Instrument

Other properties (6)

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