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Trigno Wireless Biofeedback System
EUDAMEDFDA UDIClass I (EU MDR)
Ref DS-T04
by Delsys Inc.
Identity
- Trade Name
- Trigno Wireless Biofeedback System EUDAMEDFDA UDI
- Generic Name
- Psychophysiological biofeedback system FDA UDI
- Device Name
- Trigno Wireless Biofeedback System EUDAMEDBiofeedback Device FDA UDI
- Model / Reference
- DS-T04 EUDAMEDFDA UDI
- Description
- Biofeedback Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851679007391 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851679007TWBS97 EUDAMED
- FDA Product Code
- HCC FDA UDI
- EMDN Code
- Z12062401 ELECTROMYOGRAPHIC BIOFEEDBACK SYSTEMS EUDAMED
- GMDN Term
- Psychophysiological biofeedback system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Market of Registration
- Slovenia 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Trigno Wireless Biofeedback System by Delsys, Inc. — 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 | 0851679007TWBS97 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delsys Inc.
- EUDAMED SRN
- US-MF-000037372
- Authorised Representative
- CS Life Sciences Europe Ltd IE-AR-000004113
Sources (2)
- EUDAMED add97f98-fe9b-41d8-8f81-6c652bf82220 61 fields · synced Jul 15, 2026
- FDA UDI 1803dee0-e78c-4093-8918-55a0aedff115 33 fields · synced May 30, 2026