Microwave Ablation Antennas
EUDAMEDFDA UDIClass IIb (EU MDR)
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-2450A-14 EUDAMEDFDA UDI
- Description
- Microwave Ablation Antennas FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06954414674491 EUDAMEDFDA UDI
- Basic UDI-DI
- 6954414601BG 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
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
Yes
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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Microwave ablation system probe, non-powered
Microwave Ablation Antennas by Canyon Medical Inc. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Microwave ablation system probe, non-powered.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 773188e9-5589-4b93-b841-a55697c786cd 61 fields · synced Jul 24, 2026
- FDA UDI defd6abd-bba3-4836-9c47-42bedaaab280 34 fields · synced May 30, 2026