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Power supply unit (RUTILIGHT/RUTISIDE)
EUDAMEDFDA UDIClass I (EU MDR)
Ref FA-RL01
Identity
- Trade Name
- Rutilight power supply FDA UDI
- Generic Name
- Basic power supply, reusable FDA UDI
- Device Name
- Power supply unit (RUTILIGHT/RUTISIDE) EUDAMED
- Model / Reference
- FA-RL01 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437016917015 EUDAMEDFDA UDI
- Basic UDI-DI
- 8437016917FA-RL018U EUDAMED
- FDA Product Code
- FSQ FDA UDI
- EMDN Code
- Z12020499 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER EUDAMED
- GMDN Term
- Basic power supply, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Spain 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
Yes
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
Power supply unit (RUTILIGHT/RUTISIDE) by Swan Medical, S.l — 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 | 8437016917FA-RL018U | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Swan Medical, S.l
- EUDAMED SRN
- ES-MF-000001526
Sources (2)
- EUDAMED 130feb99-c1f2-4f01-abda-4cdf580ce5d4 61 fields · synced Oct 6, 2026
- FDA UDI 5607d2cc-fc43-4b24-85a9-849023d5ccde 33 fields · synced May 29, 2026