Identity
- Trade Name
- OneTouch Reveal Insulin Mentor EUDAMED
- Device Name
- OneTouch Reveal Insulin Mentor EUDAMED
- Model / Reference
- 024167 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07613427029979 EUDAMED
- Basic UDI-DI
- 76134277029974F EUDAMED
- EMDN Code
- Z129082 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
OneTouch Reveal Insulin Mentor by LifeScan U.S. LLC — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76134277029974F | Class IIa | Active |
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Manufacturer
- Manufacturer
- LifeScan U.S. LLC
- EUDAMED SRN
- US-MF-000018448
- Authorised Representative
- LifeScan Deutschland GmbH DE-AR-000005105
Sources (1)
- EUDAMED a0db8a57-0b2c-466b-a9e2-e93f4cd8548d 61 fields · synced Jun 18, 2026