Identity
- Trade Name
- TwitchView Monitor EUDAMEDTwitchView™ FDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Device Name
- TwitchView System EUDAMEDTwitchView™ utilizes advanced electromyography (EMG) to quantify a patient's depth of neuromuscular block. Providing clinicians with reliable, accurate, and real-time data to support drug dosing and reversal timing and helps prevent residual neuromuscular blockade. FDA UDI
- Model / Reference
- TVMON01 EUDAMEDMonitor v1 FDA UDI
- Description
- TwitchView™ utilizes advanced electromyography (EMG) to quantify a patient's depth of neuromuscular block. Providing clinicians with reliable, accurate, and real-time data to support drug dosing and reversal timing and helps prevent residual neuromuscular blockade. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860298001031 EUDAMEDFDA UDI
- Basic UDI-DI
- 08602980010TVSYS3E EUDAMED
- Direct Marketing DI
- 00860298001031 EUDAMED
- 510(k) Number
- K172843 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z12062899 NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Block-monitoring peripheral nerve electrical stimulation system 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
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 Monitor 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blink Device Company
- EUDAMED SRN
- US-MF-000011459
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (2)
- EUDAMED c31bb040-f1c5-4d73-99be-1b21d1fdaecf 61 fields · synced Jul 8, 2026
- FDA UDI 0f586106-5609-4909-a820-f71736f89767 34 fields · synced May 29, 2026