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Bertec Vision Trainer (BVT) System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 95P-0014Model Type 1004
Identity
- Trade Name
- Bertec Vision Trainer System (BVT) FDA UDI
- Generic Name
- Balance/cognitive function analysis system FDA UDI
- Device Name
- Bertec Vision Trainer (BVT) System EUDAMEDThe Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static. FDA UDI
- Model / Reference
- Type 1004 EUDAMED95P-0014 EUDAMEDFDA UDI
- Description
- The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static. FDA UDI
Identifiers
- Catalog Number
- 95P-0014 FDA UDI
- Primary DI / UDI-DI
- 00850017250093 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017250TYPE1004K9 EUDAMED
- FDA Product Code
- IKK FDA UDIPTY FDA UDI
- EMDN Code
- Z120617 MOVEMENT ANALYSIS INTEGRATED SYSTEMS EUDAMED
- GMDN Term
- Balance/cognitive function analysis system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 FDA UDI882.1470 FDA UDI
- Market of Registration
- Poland 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bertec Vision Trainer (BVT) System by Bertec Corporation — 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 | 0850017250TYPE1004K9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bertec Corporation
- EUDAMED SRN
- US-MF-000008643
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 6d5ead96-e09e-4e15-b1a4-62ec77dc0e85 61 fields · synced Jun 18, 2026
- FDA UDI d1197ada-f530-4a00-8657-debcd2658c87 35 fields · synced May 30, 2026