Identity
- Trade Name
- TwitchView Large Electrode Array EUDAMEDTwitchView Large Electrode FDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Device Name
- TwitchView Electrodes EUDAMED
- Model / Reference
- TVLEA-025 EUDAMEDTVLEA025 Large Electrode FDA UDI
Identifiers
- Catalog Number
- TVLEA025 FDA UDI
- Primary DI / UDI-DI
- 00850023319180 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850023319TVACCUA EUDAMED
- Direct Marketing DI
- 00850023319180 EUDAMED
- 510(k) Number
- K172843 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMED
- GMDN Term
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
TwitchView Large Electrode Array by Blink Device Company — Class I — 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 | 0850023319TVACCUA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 c5fcc31c-d2a1-4fcb-84ef-506cde29c708 61 fields · synced Jun 18, 2026
- FDA UDI d7d88d96-4637-4d9c-a515-ed70b1245b91 35 fields · synced May 30, 2026