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Microwave Ablation Antennas
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref KY-2450B-3Model KY-2450B-T1
Identity
- Trade Name
- Microwave Ablation Antennas EUDAMEDFDA UDI
- Generic Name
- Microwave hyperthermia system applicator, intracorporeal FDA UDI
- Device Name
- Microwave Ablation Antennas EUDAMEDFDA UDI
- Model / Reference
- KY-2450B-T1 EUDAMEDKY-2450B-3 EUDAMEDFDA UDI
- Description
- Microwave Ablation Antennas FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06954414601565 EUDAMEDFDA UDI
- Basic UDI-DI
- 6954414601BG EUDAMED
- Direct Marketing DI
- 06954414601565 EUDAMED
- 510(k) Number
- K241825 FDA UDI
- FDA Product Code
- NEY FDA UDI
- EMDN Code
- Z120608 MICROWAVE THERAPY EQUIPMENT EUDAMED
- GMDN Term
- Microwave hyperthermia system applicator, intracorporeal 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microwave Ablation Antennas by Canyon Medical Inc. — 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 | 6954414601BG | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Canyon Medical Inc.
- EUDAMED SRN
- CN-MF-000022663
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED b96d3ebd-61e9-47d9-b6e1-fa6696c16447 61 fields · synced Jul 21, 2026
- FDA UDI 908ca541-47bc-4389-8fef-d3b2574ba816 34 fields · synced May 26, 2026