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Bertec Balance Advantage Prime IVR and Static Systems
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Type 1002-01/97P-0072Model Type 1002
Identity
- Trade Name
- Balance Advantage Prime IVR System FDA UDI
- Generic Name
- Posturography system platform FDA UDI
- Device Name
- Bertec Balance Advantage Prime IVR and Static Systems EUDAMEDBertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training. FDA UDI
- Model / Reference
- Type 1002 EUDAMEDType 1002-01/97P-0072 EUDAMED97P-0072 FDA UDI
- Description
- Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Immersive Virtual Reality (IVR) to enhance clinical balance assessment and training. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017250062 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017250TYPE1002K5 EUDAMED
- FDA Product Code
- KHX FDA UDI
- EMDN Code
- Z12140404 POSTUROGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Posturography system platform FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 890.1575 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 Balance Advantage Prime IVR and Static Systems by Bertec Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 0850017250TYPE1002K5 | 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 6abb9e25-b6c3-4493-b5c1-b78a064bf58c 61 fields · synced Jun 19, 2026
- FDA UDI 9e083987-0b7b-47a4-a648-38605a734671 34 fields · synced May 30, 2026