Identity
- Trade Name
- CableAME EUDAMEDFDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Device Name
- CRF-AME EUDAMEDCable Adapter FDA UDI
- Model / Reference
- CRF-AME EUDAMEDFDA UDI
- Description
- Cable Adapter FDA UDI
Identifiers
- Catalog Number
- CRF-AME FDA UDI
- Primary DI / UDI-DI
- 00811746030646 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00811746030646 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
- Electrosurgical cable adaptor 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
CableAME 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-00811746030646 | 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 48026a61-7e13-469a-82b2-46f4025583e3 61 fields · synced Jun 8, 2026
- FDA UDI fff218fa-4572-4820-b084-404e5269e611 36 fields · synced May 30, 2026