Identity
- Trade Name
- System 4 Pro EUDAMEDFDA UDI
- Generic Name
- Biomechanical function analysis system, force-testing, stationary FDA UDI
- Device Name
- Biodex System 4 EUDAMEDBiodex System 4 Pro FDA UDI
- Model / Reference
- 850-000 EUDAMEDFDA UDI
- Description
- Biodex System 4 Pro FDA UDI
Identifiers
- Catalog Number
- 850-000 FDA UDI
- Primary DI / UDI-DI
- 00718175004005 EUDAMEDFDA UDI
- Basic UDI-DI
- 07181752014S EUDAMED
- FDA Product Code
- IKK FDA UDI
- EMDN Code
- Z12062680,Z12062692 EUDAMED
- GMDN Term
- Biomechanical function analysis system, force-testing, stationary FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 890.1925 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
System 4 Pro by Biodex Medical Systems — 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 | 07181752014S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 85b2ed2d-3df1-4713-a8dc-5f586f531721 61 fields · synced Aug 2, 2026
- FDA UDI 6ca23395-eeba-4c46-823a-b0d00b56930a 34 fields · synced May 30, 2026