Identity
- Trade Name
- TwitchView Adult Electrode Array EUDAMEDTwitchView™ FDA UDI
- Generic Name
- Neuromuscular transmission electrode FDA UDI
- Device Name
- TwitchView Electrodes EUDAMEDSupporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies. FDA UDI
- Model / Reference
- TVAEA-025 EUDAMEDElectrode v1 FDA UDI
- Description
- Supporting infection control, TwitchView™ utilizes a single-patient use Electrode Array. With the flexibility to secure to either left or right hand in seconds, the Electrode Array is easily adopted into the pre-surgical workflow. The one-piece, auto-centering design mitigates placement errors—a common cause of intra-operative system failure and measurement inaccuracies. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860298001055 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850023319TVACCUA EUDAMED
- Direct Marketing DI
- 00860298001086 EUDAMED
- 510(k) Number
- K172843 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z12062885 NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES EUDAMED
- GMDN Term
- Neuromuscular transmission electrode 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TwitchView Adult 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 51a525b8-7da8-4b20-ab66-e62f1d8760af 61 fields · synced Jul 18, 2026
- FDA UDI 18634b3f-962b-4495-a511-f5735dd1e606 34 fields · synced May 30, 2026