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OneTouch Select Plus Flex

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref 024356Ref 02437201Model 024372Ref 024355Model 02435501Ref 0243540Model 024354

by LifeScan Europe GmbH

Identity

Trade Name
OneTouch Select Plus Flex EUDAMED
Device Name
OneTouch Select Plus Flex EUDAMED
Model / Reference
024356 EUDAMED
024372 EUDAMED
02437201 EUDAMED
02435501 EUDAMED
024355 EUDAMED
024354 EUDAMED
0243540 EUDAMED

Identifiers

Primary DI / UDI-DI
07613427043067 EUDAMED
07613427046914 EUDAMED
07613427042992 EUDAMED
07613427042923 EUDAMED
Basic UDI-DI
B-07613427043067 EUDAMED
B-07613427046914 EUDAMED
B-07613427042992 EUDAMED
B-07613427042923 EUDAMED
EMDN Code
W0201060102 BLOOD GLUCOSE METERS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
France EUDAMED
Romania EUDAMED
Germany EUDAMED
Belgium EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMEDEUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

OneTouch Select Plus Flex by LifeScan Europe GmbH — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
LifeScan Europe GmbH
EUDAMED SRN
CH-MF-000014224
Authorised Representative
LifeScan Deutschland GmbH DE-AR-000005105

Sources (4)

  • EUDAMED e8246ec1-f157-417b-b216-8af1cb626636 61 fields · synced Sep 18, 2026
  • EUDAMED c9e3c461-7af7-43e7-8c60-51d44e657300 61 fields · synced May 18, 2026
  • EUDAMED 319ac58f-0559-4b30-b481-3797c2228652 61 fields · synced May 18, 2026
  • EUDAMED ea144fc5-0b39-492c-8fe4-3ef95a07a431 61 fields · synced May 19, 2026