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Electrosurgical generator ESG-400
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WB91051WRef WB91051C
Identity
- Trade Name
- Electrosurgical generator ESG-400 EUDAMEDOlympus FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Electrosurgical Generators - ESG-400 EUDAMED
- Model / Reference
- WB91051W EUDAMEDFDA UDIWB91051C EUDAMED
Identifiers
- Catalog Number
- WB91051W FDA UDI
- Primary DI / UDI-DI
- 04042761076838 EUDAMEDFDA UDI04042761081931 EUDAMED
- Basic UDI-DI
- 40427611105657 EUDAMED
- Direct Marketing DI
- 04042761081931 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 ESG-400 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 | 40427611105657 | 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 (4)
- EUDAMED b0e4a22b-2ed7-4c0e-b980-118cebd31fd4 61 fields · synced Jul 27, 2026
- EUDAMED 75db0c1f-bc9f-4e38-83d0-769d4e4a5dcd 61 fields · synced May 18, 2026
- FDA UDI 5dfd6243-ad3d-4751-9bf5-c83ef64b2d8d 33 fields · synced May 30, 2026
- EUDAMED d4d611a9-69b6-4fcc-91ee-ce09c618569d 61 fields · synced Jul 8, 2026