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OneTouch Verio test strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 022922Ref 022635Ref 022259Ref 022217Ref 022296Ref 013030Ref 023043Ref 024156Ref 0222530
Identity
- Trade Name
- OneTouch Verio test strip EUDAMED
- Device Name
- OneTouch Verio test strip EUDAMED
- Model / Reference
- 022922 EUDAMED022635 EUDAMED022259 EUDAMED022217 EUDAMED022296 EUDAMED013030 EUDAMED023043 EUDAMED024156 EUDAMED0222530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427008769 EUDAMED07613427013039 EUDAMED07613427012964 EUDAMED07613427008974 EUDAMED07613427000787 EUDAMED07613427009049 EUDAMED07613427009117 EUDAMED07613427028019 EUDAMED07613427012612 EUDAMED
- Basic UDI-DI
- B-07613427008769 EUDAMEDB-07613427013039 EUDAMEDB-07613427012964 EUDAMEDB-07613427008974 EUDAMEDB-07613427000787 EUDAMEDB-07613427009049 EUDAMEDB-07613427009117 EUDAMEDB-07613427028019 EUDAMEDB-07613427012612 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain EUDAMEDFrance EUDAMEDCzechia EUDAMEDAustria EUDAMEDPortugal EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
OneTouch Verio test strip 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-07613427008769 | 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 (9)
- EUDAMED 9438f9e8-4790-4160-90cf-e28e70a9ab11 61 fields · synced Aug 4, 2026
- EUDAMED a1e67d15-9be6-4c62-8d3b-124d00279a31 61 fields · synced May 16, 2026
- EUDAMED b33c1d2b-af9d-450c-bade-825f9ad9ff21 61 fields · synced May 17, 2026
- EUDAMED 0a81a5d8-cb6f-4019-8a90-ba797c39c66a 61 fields · synced May 17, 2026
- EUDAMED e4ec227c-8d77-4e70-a4e5-01cf2e0f591f 61 fields · synced May 17, 2026
- EUDAMED d5072419-c9d3-480a-b341-4e3e33d4a5fd 61 fields · synced May 17, 2026
- EUDAMED af8b1239-4806-4d07-9f7f-c79908948521 61 fields · synced May 18, 2026
- EUDAMED 214ebce7-eb2c-4bc5-995f-8a67585a9485 61 fields · synced May 18, 2026
- EUDAMED 447557b5-46e6-42df-bf98-ca45e4448a51 61 fields · synced May 18, 2026