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OneTouch SelectPlus Flex
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023416Ref 023520Ref 023418
Identity
- Trade Name
- OneTouch SelectPlus Flex EUDAMED
- Device Name
- OneTouch SelectPlus Flex EUDAMED
- Model / Reference
- 023416 EUDAMED023520 EUDAMED023418 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427008905 EUDAMED07613427012124 EUDAMED07613427013107 EUDAMED
- Basic UDI-DI
- B-07613427008905 EUDAMEDB-07613427012124 EUDAMEDB-07613427013107 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Portugal EUDAMEDItaly EUDAMEDRomania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
OneTouch SelectPlus 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-07613427008905 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- LifeScan Europe GmbH
- EUDAMED SRN
- CH-MF-000014224
- Authorised Representative
- LifeScan Deutschland GmbH DE-AR-000005105
Sources (3)
- EUDAMED d60ee4bd-6d04-4d76-834a-9c38a11e3875 61 fields · synced Jul 29, 2026
- EUDAMED 49c27fce-685e-458f-bf65-87ba21014bad 61 fields · synced May 17, 2026
- EUDAMED 4ba771cb-c28b-42db-8d62-3919b80f97a2 61 fields · synced May 19, 2026