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Bertec Head Mounted Display (HMD System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 97P-0109Model Type 1006
Identity
- Trade Name
- Bertec Head Mounted Display System (HMD) FDA UDI
- Generic Name
- Biomechanical function analysis/rehabilitation software FDA UDI
- Device Name
- Bertec Head Mounted Display (HMD System EUDAMEDBertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training. FDA UDI
- Model / Reference
- Type 1006 EUDAMED97P-0109 EUDAMEDFDA UDI
- Description
- Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850017250116 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850017250TYPE1006KD EUDAMED
- FDA Product Code
- ISD FDA UDIKHX FDA UDI
- EMDN Code
- Z120617 MOVEMENT ANALYSIS INTEGRATED SYSTEMS EUDAMED
- GMDN Term
- Biomechanical function analysis/rehabilitation software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.5360 FDA UDI890.1575 FDA UDI
- Market of Registration
- Germany 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 Head Mounted Display (HMD 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 | 0850017250TYPE1006KD | 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 1bf47a83-95a8-4b12-ac23-bdc4deb06f1f 61 fields · synced Jul 11, 2026
- FDA UDI 1b7ac179-54db-4232-8f8e-dae08e522026 34 fields · synced May 30, 2026