← Back to catalogue
OneTouch Select Plus test strip
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023238Ref 023226Ref 023230Ref 012915Ref 024249Ref 024147Ref 012922Ref 012916
Identity
- Trade Name
- OneTouch Select Plus test strip EUDAMED
- Device Name
- OneTouch Select Plus test strip EUDAMED
- Model / Reference
- 023238 EUDAMED023226 EUDAMED023230 EUDAMED012915 EUDAMED024249 EUDAMED024147 EUDAMED012922 EUDAMED012916 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427009186 EUDAMED07613427012759 EUDAMED07613427001418 EUDAMED07613427006109 EUDAMED07613427036625 EUDAMED07613427024370 EUDAMED07613427009674 EUDAMED07613427001906 EUDAMED
- Basic UDI-DI
- B-07613427009186 EUDAMEDB-07613427012759 EUDAMEDB-07613427001418 EUDAMEDB-07613427006109 EUDAMEDB-07613427036625 EUDAMEDB-07613427024370 EUDAMEDB-07613427009674 EUDAMEDB-07613427001906 EUDAMED
- EMDN Code
- W0101060101 GLUCOSE TEST STRIPS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Spain EUDAMEDPoland EUDAMEDCzechia EUDAMEDBelgium EUDAMEDGermany 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
EUDAMEDEUDAMED
Near-Patient Testing
Yes
EUDAMEDEUDAMED
Professional Testing
No
EUDAMEDEUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
OneTouch Select 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-07613427009186 | Class IVD Annex II List B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LifeScan Europe GmbH
- EUDAMED SRN
- CH-MF-000014224
- Authorised Representative
- LifeScan Deutschland GmbH DE-AR-000005105
Sources (8)
- EUDAMED 8d676b8f-9331-46ac-85da-c3fae5861023 61 fields · synced Jul 31, 2026
- EUDAMED b854e8c8-7b68-4258-9e82-9fb73b9d1e8f 61 fields · synced May 16, 2026
- EUDAMED da6f5d0b-802a-4598-a6d5-34d4865b2b60 61 fields · synced May 16, 2026
- EUDAMED a889e6f4-39a4-4f83-9397-3202ddf2244e 61 fields · synced May 17, 2026
- EUDAMED 8575d410-f388-462a-a89a-356aa2a315c8 61 fields · synced May 17, 2026
- EUDAMED a9f70374-587d-40f1-b7a6-b7402ca97389 61 fields · synced May 17, 2026
- EUDAMED b4373d3b-f366-4c50-9364-f153a901e742 61 fields · synced May 18, 2026
- EUDAMED 142aef99-6c35-442d-a1b9-3a59beef9cd6 61 fields · synced May 18, 2026