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OneTouch Verio Reflect
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023909Ref 024054Ref 023911Ref 023917Ref 024076Ref 023913Ref 023916
Identity
- Trade Name
- OneTouch Verio Reflect EUDAMED
- Device Name
- OneTouch Verio Reflect EUDAMED
- Model / Reference
- 023909 EUDAMED024054 EUDAMED023911 EUDAMED023917 EUDAMED024076 EUDAMED023913 EUDAMED023916 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427000152 EUDAMED07613427003726 EUDAMED07613427000299 EUDAMED07613427002460 EUDAMED07613427343228 EUDAMED07613427003375 EUDAMED07613427003443 EUDAMED
- Basic UDI-DI
- B-07613427000152 EUDAMEDB-07613427003726 EUDAMEDB-07613427000299 EUDAMEDB-07613427002460 EUDAMEDB-07613427343228 EUDAMEDB-07613427003375 EUDAMEDB-07613427003443 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- France EUDAMEDBelgium EUDAMEDPortugal EUDAMEDCzechia EUDAMEDAustria EUDAMEDItaly 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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
OneTouch Verio Reflect 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-07613427000152 | 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 (7)
- EUDAMED 5885ef0c-96fd-4fbe-88dc-78debf49ac36 61 fields · synced Jul 16, 2026
- EUDAMED 0d18892a-ae22-4c58-9458-7e7dc68eb865 61 fields · synced May 17, 2026
- EUDAMED c78b3400-affd-4f92-bcd9-25261f5ae754 61 fields · synced May 17, 2026
- EUDAMED ceab363a-989e-40b8-9aee-3a1b01d667a3 61 fields · synced May 17, 2026
- EUDAMED d8f79368-39e0-49e5-acbe-a997f9c5b660 61 fields · synced May 18, 2026
- EUDAMED 29508723-f1b2-424e-86b4-0aa900257b90 61 fields · synced May 18, 2026
- EUDAMED e54c043d-89b6-45b9-a4c4-c8b5c9f59652 61 fields · synced May 18, 2026