Identity
- Trade Name
- silverfox FDA UDI
- Generic Name
- Examination/treatment table, line-powered FDA UDI
- Device Name
- Physiotherapy Table EUDAMED
- Model / Reference
- NRUN EVO 5S EUDAMEDNRun-304(HT) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973134770245 EUDAMEDFDA UDI
- Basic UDI-DI
- 697313477NRUNEVO5SA6699 EUDAMED
- Direct Marketing DI
- 06973134770245 EUDAMED
- FDA Product Code
- FNL FDA UDI
- EMDN Code
- Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED
- GMDN Term
- Examination/treatment table, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5100 FDA UDI
- Market of Registration
- Italy 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
Physiotherapy Table by Silverfox Corporation Limited — 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 | 697313477NRUNEVO5SA6699 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Silverfox Corporation Limited
- EUDAMED SRN
- CN-MF-000008252
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED df74aa69-b5e9-4732-b2c9-0df88664fa0d 61 fields · synced Jul 15, 2026
- FDA UDI 6d2e1154-9d98-40f9-9916-8751b68b8956 32 fields · synced May 30, 2026