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OneTouch ShareVue™
EUDAMEDClass IIb (EU MDR)
Ref HS-MA-06, HS-WA-14
by i-SENS, Inc.
Identity
- Trade Name
- OneTouch ShareVue™ EUDAMED
- Device Name
- Glucose Data Management Software EUDAMED
- Model / Reference
- HS-MA-06, HS-WA-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806712011400 EUDAMED
- Basic UDI-DI
- 8806712CGMDM001UV EUDAMED
- EMDN Code
- Z1204011599 BLOOD SUGAR MONITORING SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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 ShareVue™ by i-SENS, Inc. — Class IIb — 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 | 8806712CGMDM001UV | Class IIb | Active |
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Manufacturer
- Manufacturer
- i-SENS, Inc.
- EUDAMED SRN
- KR-MF-000009173
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED bf27c4f8-cfce-483e-9c30-7be8fee1684b-1 61 fields · synced Jul 21, 2026
- EUDAMED bf27c4f8-cfce-483e-9c30-7be8fee1684b-2 61 fields · synced Jul 21, 2026