Identity
- Trade Name
- TwitchView Patient Cable (12') EUDAMEDTwitchView™ FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- TwitchView System EUDAMEDA reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array. FDA UDI
- Model / Reference
- TVCAB02 EUDAMEDCable Assembly v1 12' FDA UDI
- Description
- A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860298001093 EUDAMEDFDA UDI
- Basic UDI-DI
- 08602980010TVSYS3E EUDAMED
- Direct Marketing DI
- 00860298001093 EUDAMED
- 510(k) Number
- K172843 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TwitchView Patient Cable (12') by Blink Device Company — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08602980010TVSYS3E | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 608911e4-ebfc-4e21-89c3-45c6650b880b 61 fields · synced Jul 25, 2026
- FDA UDI 2a8c1f9a-f4b2-4632-9799-99b768568288 34 fields · synced May 29, 2026