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Device Explorer · FDA GUDID · GMDN 61286

Microwave ablation system probe, non-powered

A non-active, hand-held surgical instrument designed to connect to a microwave ablation system generator to deliver microwaves to a targeted operative site for localized soft-tissue ablation, typically to treat tumours, hydatid cysts and/or menorrhagia. The pr

US‑registered devices92in commercial distribution
Companies10labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Medwaves, Inc.1617%
Hygea Medical Technology Co., Ltd.1516%
Neuwave Medical, Inc.1516%
Covidien Lp1516%
Mima-Pro (Nan Tong) Scientific Inc.910%
Betters (Suzhou)Medical Co., Ltd.89%
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.67%
Perseon Corporation55%

Top labelers

CompanyDevicesShare
Medwaves, Inc.1617%
Hygea Medical Technology Co., Ltd.1516%
Neuwave Medical, Inc.1516%
Covidien Lp1516%
Mima-Pro (Nan Tong) Scientific Inc.910%
Betters (Suzhou)Medical Co., Ltd.89%
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.67%
Perseon Corporation55%
Microcube, Llc22%
Creo Medical Limited11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Betters (Suzhou)Medical Co., Ltd.HYGEAMicroBlate FineAvecureNEUWAVESynchroWave Antenna KitMinitouchMima-ProDophiEmprintEmprint SX

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
NEYSystem, Ablation, Microwave And Accessories92
NEYSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES52
GEIElectrosurgical, cutting & coagulation & accessories24
MNBDevice, Thermal Ablation, Endometrial2

GMDN & GCC registration

  • GMDN code 61286 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 32Outer Diameter (Millimeter) · 4Length (Meter) · 2

Use these as the dimensions to specify in a tender line.

How many microwave ablation system probe, non-powered products are registered in the US?

92 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Microwave ablation system probe, non-powered", from 10 companies. The largest labeler is Medwaves, Inc. with 17% of records.

Which FDA product codes apply?

NEY (System, Ablation, Microwave And Accessories), NEY (SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES), GEI (Electrosurgical, cutting & coagulation & accessories), MNB (Device, Thermal Ablation, Endometrial)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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