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OneTouch Ultra Plus Control Solution
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023810Ref 024065
Identity
- Trade Name
- OneTouch Ultra Plus Control Solution EUDAMED
- Device Name
- OneTouch Ultra Plus Control Solution EUDAMED
- Model / Reference
- 023810 EUDAMED024065 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427007014 EUDAMED07613427004983 EUDAMED
- Basic UDI-DI
- B-07613427007014 EUDAMEDB-07613427004983 EUDAMED
- EMDN Code
- W0101050205 DIABETES CONTROLS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
OneTouch Ultra Plus Control Solution 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-07613427007014 | 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 (2)
- EUDAMED b7af58e9-fcea-4ae8-ba3a-6fd4cb49b25f 61 fields · synced Jul 26, 2026
- EUDAMED 9499f1c7-3bf3-4e00-aa0b-35b1f69d1c4b 61 fields · synced May 19, 2026