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Electrosurgical generator, E-Type CELON Precision
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA90008A
Identity
- Trade Name
- Electrosurgical generator, E-Type CELON Precision EUDAMEDOlympus FDA UDI
- Generic Name
- Electrosurgical system generator FDA UDI
- Device Name
- Electrosurgical Generators - CELON PRECISION EUDAMED
- Model / Reference
- WA90008A EUDAMEDFDA UDI
Identifiers
- Catalog Number
- WA90008A FDA UDI
- Primary DI / UDI-DI
- 04042761082976 EUDAMEDFDA UDI
- Basic UDI-DI
- 4042761110755B 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 Precision by Olympus Winter & Ibe GmbH — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4042761110755B | 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 7a6b84a2-36fa-45dd-9ba2-e68b5d50e16e 61 fields · synced Aug 2, 2026
- FDA UDI 6bcf207f-9104-42ae-823b-bc3240932f69 33 fields · synced May 30, 2026