Identity
- Trade Name
- TwitchView System EUDAMED
- Device Name
- TwitchView System EUDAMED
- Model / Reference
- TVSYS01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860298001062 EUDAMED
- Basic UDI-DI
- 08602980010TVSYS3E EUDAMED
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
TwitchView System by Blink Device Company — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192958 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08602980010TVSYS3E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Blink Device Company
- EUDAMED SRN
- US-MF-000011459
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED 71933ced-01c9-48ef-8e31-539ce8e015cc 61 fields · synced Jun 19, 2026
- FDA 510(k) K192958 1 fields · synced May 18, 2026