Identity
- Trade Name
- HybridTherm® bipolar EUDAMEDErbe FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
- Device Name
- HybridTherm probes EUDAMEDHybridTherm® bipolar; ø 1,9mm; L 1,25m FDA UDI
- Model / Reference
- 20220-100 EUDAMEDFDA UDI
- Description
- HybridTherm® bipolar; ø 1,9mm; L 1,25m FDA UDI
Identifiers
- Catalog Number
- 20220-100 FDA UDI
- Primary DI / UDI-DI
- 04050147022751 EUDAMEDFDA UDI
- Basic UDI-DI
- 4050147HybridTherm-SU-79 EUDAMED
- Direct Marketing DI
- 04050147022751 EUDAMED
- 510(k) Number
- K240932 FDA UDI
- FDA Product Code
- GEI FDA UDIGEH FDA UDIJOS FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, bipolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4350 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 1250 Millimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Erbe by Erbe Elektromedizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (2)
- FDA UDI 80ff1904-34d2-445e-96c6-9e679cd45d42 38 fields · synced Jun 19, 2026
- EUDAMED 81a940b6-0247-4f73-a952-ef58fc62728d 61 fields · synced Jun 19, 2026