Surgitron 4.0 Dual Rf/90 Iec 220-240v
EUDAMEDFDA UDIClass IIb (EU MDR)
by Cynosure LLC
Identity
- Trade Name
- SURGITRON 4.0 DUAL RF/90 IEC 220-240V EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- SURGITRON 4.0 DUAL RF/90 IEC 220-240V EUDAMEDFDA UDI
- Model / Reference
- IEC3A-S30-90/220 EUDAMEDFDA UDI
- Description
- SURGITRON 4.0 DUAL RF/90 IEC 220-240V FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494108472 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841494108472 EUDAMED
- 510(k) Number
- K013255 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Electrosurgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Microwave ablation system probe, non-powered
Surgitron 4.0 Dual Rf/90 Iec 220-240v by Cynosure, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841494108472 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cynosure LLC
- EUDAMED SRN
- US-MF-000010200
- Authorised Representative
- Cynosure B.V. NL-AR-000009566
Sources (2)
- EUDAMED 07194715-f91b-4cc9-afd2-de8d41da23eb 61 fields · synced Oct 6, 2026
- FDA UDI 3cd483bf-d4ef-40ff-86bb-0b83a054f3a0 34 fields · synced May 30, 2026