Microwave Ablation Antennas

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref KY-2BAC-24AModel KY-2450B-T1

by Canyon Medical Inc.

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 EUDAMED
KY-2BAC-24A EUDAMEDFDA UDI
Description: Microwave Ablation Antennas FDA UDI

Identifiers

Primary DI / UDI-DI: 06954414601053 EUDAMEDFDA UDI
Basic UDI-DI: 6954414601BG EUDAMED
Direct Marketing DI: 06954414601053 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 EUDAMED
Class 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

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

Similar devices

Also classified as Microwave ablation system probe, non-powered.

TempSure System, Surgical — Cynosure, LLC · Class IIb
SURGITRON 4.0 DUAL RF/90 IEC 220-240V — Cynosure, LLC · Class IIb
Swift® — Emblation , Ltd. · Class I
Mima-Pro — Mima-Pro (Nan Tong) Scientific Inc. · Class II
Microwave Ablation Electrode Kit — SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD. · Class IIb
Betters (Suzhou)Medical Co., Ltd. — Betters(Suzhou) Medical Co., Ltd. · Class II
Avecure — Medwaves, Inc. · Class II
Microblate Flex — Creo Medical, Ltd. · Class II

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 1a7b6fc9-5a69-4b76-9f41-ce5e6cf03b4e 61 fields · synced Sep 18, 2026
FDA UDI 51e6a86b-5e72-4e26-8738-cecbbb78ad44 34 fields · synced May 30, 2026