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OneTouch SelectPlus
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 023210Ref 023211Ref 023768Ref 023208Ref 023769Ref 023216Ref 023767
Identity
- Trade Name
- OneTouch SelectPlus EUDAMED
- Device Name
- OneTouch SelectPlus EUDAMED
- Model / Reference
- 023210 EUDAMED023211 EUDAMED023768 EUDAMED023208 EUDAMED023769 EUDAMED023216 EUDAMED023767 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427005614 EUDAMED07613427013176 EUDAMED07613427008202 EUDAMED07613427013732 EUDAMED07613427008271 EUDAMED07613427011981 EUDAMED07613427008134 EUDAMED
- Basic UDI-DI
- B-07613427005614 EUDAMEDB-07613427013176 EUDAMEDB-07613427008202 EUDAMEDB-07613427013732 EUDAMEDB-07613427008271 EUDAMEDB-07613427011981 EUDAMEDB-07613427008134 EUDAMED
- EMDN Code
- W0201060102 BLOOD GLUCOSE METERS EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Germany EUDAMEDRomania EUDAMEDFrance EUDAMEDPoland EUDAMEDPortugal 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
No
EUDAMEDEUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
OneTouch SelectPlus 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-07613427005614 | 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 c30fc3b1-4839-4911-9970-2bb8a815073f 61 fields · synced Sep 17, 2026
- EUDAMED 6afc19d6-f8ed-4b21-b278-bf026c7c50b1 61 fields · synced May 16, 2026
- EUDAMED 24c026dd-938b-44fc-ac27-a75a54c5d588 61 fields · synced May 16, 2026
- EUDAMED c27bee75-86c1-449e-9f7e-bea738f83533 61 fields · synced May 17, 2026
- EUDAMED f5f90d9e-7695-478c-bff0-f4d12a6ec595 61 fields · synced May 18, 2026
- EUDAMED 11b8d26d-b12a-416f-a0ea-1a1e7c5d65a0 61 fields · synced May 18, 2026
- EUDAMED 14203fc7-80db-4d90-8018-697479b60ac5 61 fields · synced May 18, 2026