Identity
- Trade Name
- OneTouch Reveal Web Application EUDAMED
- Device Name
- OneTouch Reveal Web Application HCP EUDAMED
- Model / Reference
- 024169 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427030111 EUDAMED
- Basic UDI-DI
- B-07613427030111 EUDAMED
- EMDN Code
- W020106019092 VARIOUS DIABETES MONITORING INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
OneTouch Reveal Web Application by LifeScan Europe GmbH — Class IVD General — 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-07613427030111 | Class IVD General | 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 (1)
- EUDAMED 5aae9de1-7ff7-451e-853d-8a0461b23e46 61 fields · synced Jun 19, 2026