Identity
- Trade Name
- ElectrodeCRF EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI
- Device Name
- CRF-U2010P EUDAMEDCRF Radiofrequency Electrode FDA UDI
- Model / Reference
- CRF-U2010P EUDAMEDFDA UDI
- Description
- CRF Radiofrequency Electrode FDA UDI
Identifiers
- Catalog Number
- CRF-U2010P FDA UDI
- Primary DI / UDI-DI
- 00811746032473 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00811746032473 EUDAMED
- 510(k) Number
- K192715 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, bipolar FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Foot-switch, electrical
ElectrodeCRF by Cambridge Interventional LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00811746032473 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cambridge Interventional LLC
- EUDAMED SRN
- US-MF-000021911
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED bbc0cf76-1bfb-45e8-926e-18d210b3cdb2 61 fields · synced Jul 27, 2026
- FDA UDI 7bd35af0-74c4-4915-a41a-94891d4d67c5 36 fields · synced May 30, 2026