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OneTouch Ultra Plus test strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 024064Ref 0238620Ref 024248
Identity
- Trade Name
- OneTouch Ultra Plus test strip EUDAMED
- Device Name
- OneTouch Ultra Plus test strip EUDAMED
- Model / Reference
- 024064 EUDAMED0238620 EUDAMED024248 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427004709 EUDAMED07613427006598 EUDAMED07613427036557 EUDAMED
- Basic UDI-DI
- B-07613427004709 EUDAMEDB-07613427006598 EUDAMEDB-07613427036557 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMEDBelgium 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 Ultra Plus 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-07613427004709 | 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 97d886c5-c762-4893-b4f2-d273f8563b6a 61 fields · synced Jul 25, 2026
- EUDAMED 1a60a47e-e196-4fb8-93be-35ad981a6154 61 fields · synced May 17, 2026
- EUDAMED 5d3c6fb8-737c-48da-a45f-aeb1d8f85f8a 61 fields · synced May 17, 2026