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Bertec Vision Advantage (BVA) System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 97P-0037Model Type 1003
Identity
- Trade Name
- Bertec Vision Advantage FDA UDI
- Generic Name
- Dynamic visual acuity testing system FDA UDI
- Device Name
- Bertec Vision Advantage (BVA) System EUDAMEDBertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer. FDA UDI
- Model / Reference
- Type 1003 EUDAMED97P-0037 EUDAMEDFDA UDI
- Description
- Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a laptop computer with a wireless remote controller, a wireless inertial measurement unit (IMU) that measures the 3-dimensional angles, velocities, and accelerations, and a headband. The headband holds the IMU in a small pouch, which allows tracking of the head movements. The remote controller is used to input the patient’s responses to the computer. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017250000 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017250TYPE1003K7 EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z12140401 VESTIBULAR ASSESSMENT SYSTEMS EUDAMED
- GMDN Term
- Dynamic visual acuity testing system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1150 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bertec Vision Advantage (BVA) 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 | 0850017250TYPE1003K7 | 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 a163c8c8-5e35-449a-b8f5-78b5bbe1a253 61 fields · synced Jun 18, 2026
- FDA UDI e107552f-17b7-4cb1-a52b-b0a86b9523a2 34 fields · synced May 30, 2026