Identity
- Trade Name
- BALANCE SYSTEM SD 230V EUDAMEDBALANCE SD FDA UDI
- Generic Name
- Posturography system FDA UDI
- Device Name
- Balance System EUDAMEDBalance System SD, 230 VAC FDA UDI
- Model / Reference
- 950-441 EUDAMEDFDA UDI
- Description
- Balance System SD, 230 VAC FDA UDI
Identifiers
- Catalog Number
- 950-441 FDA UDI
- Primary DI / UDI-DI
- 00718175000045 EUDAMEDFDA UDI
- Basic UDI-DI
- 07181752095A EUDAMED
- FDA Product Code
- KHX FDA UDI
- EMDN Code
- Z12140404 POSTUROGRAPHY SYSTEMS EUDAMED
- GMDN Term
- Posturography system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1575 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
Yes
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
Balance System Sd 230v by Biodex Medical Systems — 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 | 07181752095A | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodex Medical Systems
- EUDAMED SRN
- US-MF-000028834
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED d6c3dc6b-94c7-45c2-ad19-47131131e5a0 61 fields · synced Jun 17, 2026
- FDA UDI dc48cce7-c587-4ccd-a2fd-0cd3f9250f95 34 fields · synced May 30, 2026