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Electrosurgical generator, E-Type CELON ELITE ESG-200
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref WA90001A
Identity
- Trade Name
- Electrosurgical generator, E-Type CELON ELITE ESG-200 EUDAMEDOlympus FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Electrosurgical Generators - CELON ELITE EUDAMED
- Model / Reference
- WA90001A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- WA90001A FDA UDI
- Primary DI / UDI-DI
- 04042761082952 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611107459 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS 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
- Germany 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
No
FDA UDI
Electrosurgical generator, E-Type CELON ELITE ESG-200 by Olympus Winter & Ibe GmbH — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160639 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 40427611107459 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
- EUDAMED SRN
- DE-MF-000006729
Sources (3)
- EUDAMED dc33fd4d-37b5-4595-9233-a46bb37d2cf2 61 fields · synced Jun 18, 2026
- FDA UDI 4e4021da-e998-434c-86d4-daa2e12d578b 33 fields · synced May 30, 2026
- FDA 510(k) K160639 1 fields · synced May 18, 2026