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OneTouch Verio Flex
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023183Ref 023190Ref 023188
Identity
- Trade Name
- OneTouch Verio Flex EUDAMED
- Device Name
- OTV FlexMeter mg AT/DE/BE (LE) EUDAMEDOneTouch Verio Flex EUDAMED
- Model / Reference
- 023183 EUDAMED023190 EUDAMED023188 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427001838 EUDAMED07613427002323 EUDAMED07613427001272 EUDAMED
- Basic UDI-DI
- B-07613427001838 EUDAMEDB-07613427002323 EUDAMEDB-07613427001272 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Austria EUDAMEDGermany EUDAMEDCzechia 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
Yes
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
OneTouch Verio 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-07613427001838 | 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 62983ef4-bbc3-4dbe-b704-35e8cb1435e1 61 fields · synced Jul 18, 2026
- EUDAMED 42925c49-210b-42f2-a805-50e36445631f 61 fields · synced May 17, 2026
- EUDAMED 0274eb26-dc3a-455a-a387-d7f28643d16c 61 fields · synced Jul 15, 2026