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Electrosurgical generator ESG-410
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA91307W
Identity
- Trade Name
- Electrosurgical generator ESG-410 EUDAMEDOlympus FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Electrosurgical Generators - ESG-410 EUDAMEDElectrosurgical generator "ESG-410" FDA UDI
- Model / Reference
- WA91307W EUDAMEDFDA UDI
- Description
- Electrosurgical generator "ESG-410" FDA UDI
Identifiers
- Catalog Number
- WA91307W FDA UDI
- Primary DI / UDI-DI
- 04042761086332 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611105759 EUDAMED
- 510(k) Number
- K203277 FDA UDI
- 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
Yes
FDA UDI
Electrosurgical generator ESG-410 by Olympus Winter & Ibe GmbH — Class IIb — 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 | 40427611105759 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
- EUDAMED SRN
- DE-MF-000006729
Sources (2)
- EUDAMED 02112975-bbd3-4661-abe0-4aca6a874b8e 61 fields · synced Oct 6, 2026
- FDA UDI e303d17e-1870-4f57-ae32-e1cdd1ad6496 36 fields · synced May 30, 2026