Identity
- Trade Name
- SYSTEM 5000 EUDAMEDFDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Non-orthopedic, Active, Electrosurgical Generator, General purpose, System 5000 EUDAMEDSYSTEM 5000 100 - 230 VAC 50/60 Hz Electrosurgical Unit FDA UDI
- Model / Reference
- 60-8005-002 EUDAMEDFDA UDI
- Description
- SYSTEM 5000 100 - 230 VAC 50/60 Hz Electrosurgical Unit FDA UDI
Identifiers
- Catalog Number
- 60-8005-002 FDA UDI
- Primary DI / UDI-DI
- 20653405040207 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20653405040207 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE 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
- Belgium 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
System 5000 by Conmed Corporation — Class IIb — MDD, 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/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20653405040207 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Conmed Corporation
- EUDAMED SRN
- US-MF-000012663
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0c6b58b8-5d62-40c8-9862-74eafaa3d7f3 61 fields · synced May 30, 2026
- FDA UDI 4e715da5-2dec-41b3-b7e3-5b0b33a4db17 36 fields · synced May 30, 2026