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Surtron 400 Hp
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 10400.902Model SURTRON TOUCH HP 400
by LED SpA
Identity
- Trade Name
- SURTRON 400 HP EUDAMEDSURTRON FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- SURTRON TOUCH HP 400 EUDAMEDSURTRON device model 400HP is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 400HP is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 400W and frequency of 425kHz. FDA UDI
- Model / Reference
- SURTRON TOUCH HP 400 EUDAMED10400.902 EUDAMED400HP FDA UDI
- Description
- SURTRON device model 400HP is an ElectroSurgical Unit including monopolar and bipolar technology. SURTRON 400HP is intended for use with accessories during surgical procedures where the surgeon requires electrosurgical cutting and coagulating. Maximum output power is 400W and frequency of 425kHz. FDA UDI
Identifiers
- Catalog Number
- 10400.902/US FDA UDI
- Primary DI / UDI-DI
- 08033638321911 EUDAMEDFDA UDI
- Basic UDI-DI
- 803363832HFS00144 EUDAMED
- Direct Marketing DI
- 08033638321911 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Foot-switch, electrical
Surtron 400 Hp by Led Spa — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 803363832HFS00144 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LED SpA
- EUDAMED SRN
- IT-MF-000012232
Sources (2)
- EUDAMED a11166de-5c79-48a5-b429-54a22e7083f1 61 fields · synced May 30, 2026
- FDA UDI 4f08a397-1a81-4c37-9bd2-ebb11f1a1c3a 35 fields · synced May 30, 2026