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Device Explorer · FDA GUDID · GMDN 45738

General cryosurgical system, cryogen gas, electronic

An assembly of electrically-powered devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for destruction and removal. The s

US‑registered devices70in commercial distribution
Companies11labelers on GUDID
Single‑use46%of device records
Sterile46%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Hygea Medical Technology Co., Ltd.2231%
Boston Scientific Corporation2130%
Medinux (Tianjin) Technologies Co., Ltd.1217%
Icecure Medical Ltd46%
Varian Medical Systems, Inc.34%
Focused Cryo, Inc.23%
Channel Medsystems, Inc.23%
Coopersurgical, Inc.11%

Top labelers

CompanyDevicesShare
Hygea Medical Technology Co., Ltd.2231%
Boston Scientific Corporation2130%
Medinux (Tianjin) Technologies Co., Ltd.1217%
Icecure Medical Ltd46%
Varian Medical Systems, Inc.34%
Focused Cryo, Inc.23%
Channel Medsystems, Inc.23%
Coopersurgical, Inc.11%
Merit Medical Systems, Inc.11%
Sanarus Technologies, Inc.11%
Pacira Pharmaceuticals, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

External 25L DewarXSense Cryoablation SystemPROSENSE™ SYSTEM 100-127 VACCryoThinHYGEAHer OptionC2 CryoBalloon™Visica 2Focused Cryotherapy System Directional CryoprobeFocused Cryotherapy System ConsoleVisual-ICE® Cryoablation System - EvaluationVisual-ICE® Cryoablation System - Zero CostVisual-ICE® Cryoablation System - RefurbishedVisual-ICE® Cryoablation System - Customer OwnedICEfx Cryoablation System - EvaluationICEfx Cryoablation System - Zero Cost

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

FDA product codes

CodeNameDevices
GEHUnit, Cryosurgical, Accessories79
GEHUNIT, CRYOSURGICAL, ACCESSORIES12
MNBDevice, Thermal Ablation, Endometrial4
QXWCryoablation Device For Local Treatment Of Low-Risk Breast C2
GXHDevice, Surgical, Cryogenic2

GMDN & GCC registration

  • GMDN code 45738 · non‑implantable
  • Single‑use 46% · sterile 46% · Rx‑only 97% · 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 (Meter) · 16Weight (Kilogram) · 3Height (Inch) · 2Width (Inch) · 2Depth (Inch) · 2Depth (Millimeter) · 1

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

How many general cryosurgical system, cryogen gas, electronic products are registered in the US?

70 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General cryosurgical system, cryogen gas, electronic", from 11 companies. The largest labeler is Hygea Medical Technology Co., Ltd. with 31% of records.

Which FDA product codes apply?

GEH (Unit, Cryosurgical, Accessories), GEH (UNIT, CRYOSURGICAL, ACCESSORIES), MNB (Device, Thermal Ablation, Endometrial), QXW (Cryoablation Device For Local Treatment Of Low-Risk Breast C)

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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