Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments
Cryosurgery equipment
EMDN code Z120102
Manufacturers registered in Europe (EUDAMED) 21
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 82
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Coopersurgical, Inc. Present in Europe in other categories | United States | Frigitronics Wallach Leisegang Cryotip for LM-900 CooperSurgical, Inc. Wallach UltraFreeze Wallach LL100 | registered |
| Brymill Corp. | United States | Original Bent Spray Cryo Tweezers 8mm Ball Probes 3in x 18g Straight Spray Sharp Pointed Conical Probes 4mm Conical Probes | K072453 (2007) |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Premier Premier-CryOmega Premier CryOmega | K970992 (1997) |
| C2 Therapeutics, Inc. | United States | C2 CryoBalloon C2 CryoBalloon Focal Controller C2 CryoBalloon Swipe Catheter, Standard C2 CryoBalloon Cartridge, Regular C2 CryoBalloon Focal Catheter, Standard C2 CryoBalloon Full 8 Catheter | K163684 (2018) |
| Cryosurgery, Inc. | United States | Verruca-Freeze Verruca-Freeze H | K253000 (2025) |
| Mira, Inc. | United States | MIRA Cryosurgical Probe, Curved Retinal MIRA Cryosurgical Probe, Straight Vitreous MIRA Cryosurgical Console MIRA Cryosurgical Probe, Mini Curved Cataract MIRA Cryosurgical Probe, Abramson Retinoblastoma MIRA Cryosurgical Probe, Straight Mini Vitreous | registered |
| Nuance Medical, LLC | United States | CryoDose CryoDose H | K210310 (2021) |
| SCHOLL'S WELLNESS COMPANY LLC Present in Europe in other categories | United States | Freeze Away Wart Remover Dr Scholls Freeze Away 7ct Blue Freeze Away Max Plantar Wart Remover Freeze Away Pinpoint Skin Tag Remover Freeze Away Dual Action 8ct Dr Scholls Freeze Away 7ct Yellow | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Miltex® | registered |
| R2 Technologies, Inc. | United States | Dermal Cooling System | K201260 (2020) |
| US Endoscopy | United States | truFreeze | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | – | CVS Health CVS Skin Tag Remover | registered |
| Medtech Products, Inc. Present in Europe in other categories | United States | Compound W® | K242803 (2024) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | ICEOUT™ FREEZPOINT™ | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| MOORE MEDICAL LLC | – | Moore Medical | registered |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | C2 CryoBalloon™ | registered |
| Arrinex, Inc. | United States | ClariFix | K190356 (2019) |
| Cool Renewal, LLC | United States | COOL RENEWAL | K161296 (2016) |
| WAL-MART STORES, INC. | – | Equate Equate™ | registered |
| WALGREEN CO. | – | Walgreens Walgreens Freeze Skin Tag Remover Well at Walgreens | registered |
| SANARUS TECHNOLOGIES, INC. | – | Visica 2 V2 ICE Probe SL V2 ICE PROBE | registered |
| Cynosure, Inc. Present in Europe in other categories | United States | FRIGI-DENT | registered |
| Dgi Group LLC | United States | Claritag Advanced | registered |
| Eigen Health Services LLC | – | Artemis-TPOS Artemis | registered |
| MEIJER, INC. | – | Meijer meijer Wart Freezer | registered |
| Recensmedical, Inc. | South Korea | TargetCool TargetCool-e | K253114 (2025) |
| STRYKER CORPORATION Present in Europe in other categories | United States | ClariFix | registered |
| Ahold U.S.A., Inc. | – | CareOne | registered |
| Aso LLC | United States | Care Science | registered |
| Bibawo Medical A/S | Denmark | Hydrozid | K221897 (2023) |
| H. E. BUTT GROCERY COMPANY | – | H.E.B Wart Freezer | registered |
| HY-VEE, INC. | – | HyVee | registered |
| MedGyn Products, Inc. | United States | MedGyn MGC-200 Cryotherapy System | registered |
| OraSure Technologies, Inc. Present in Europe in other categories | United States | Rite Aid | K060859 (2006) |
| TARGET CORPORATION | – | Up&Up | registered |
| TheOTCLab B.V. | – | Dr Yglo | registered |
| Topco Associates, LLC | – | TopCare | registered |
| UC-CARE , Ltd. | Israel | Warming System-unit, Cryosurgical | K090978 (2009) |
| B.M. Tech. Worldwide Co., Ltd. | South Korea | – | K182392 (2018) |
| BRYMILL CORP. DBA Brymill Cryogenic Systems | United States | – | registered |
| Biomerics | United States | – | registered |
| Bovie Medical Corporation | United States | – | K180211 (2018) |
| Brymill Cryogenic Systems | United States | – | K193619 (2020) |
| CSA Medical, Inc. | United States | – | K201183 (2020) |
| Chaban Medical | Israel | – | registered |
| Cry IQ AB | Sweden | – | K172049 (2017) |
| Cryofos Medical GmbH | Germany | – | K170810 (2017) |
| Csa Medial, Inc. | United States | – | K160273 (2016) |
| Dgi Technologies | United States | – | K222356 (2023) |
| Eigen | United States | – | registered |
| Endocision Technologies, Inc. | Canada | – | K240776 (2024) |
| Foamtec International Co., Ltd. | Thailand | – | registered |
| Focused Cryo, Inc. | United States | – | K250742 (2025) |
| Galil Medical , Ltd. | United States | – | K203032 (2020) |
| H&O Equipments NV/Clinic6 | Belgium | – | registered |
| Healthtronics | United States | – | K153489 (2016) |
| Hologic, Inc. Present in Europe in other categories | United States | – | registered |
| Hubot, Inc. | United States | – | registered |
| Intuitive Surgical, Inc. Present in Europe in other categories | United States | – | registered |
| MCAM Hungary Kft. | Hungary | – | registered |
| Medical Brands Laboratories B.V. | Netherlands | – | K252198 (2026) |
| Medilink A/S | Denmark | – | K201740 (2021) |
| Medinice S.A. Present in Europe in other categories | Poland | – | K251928 (2026) |
| NOVEM MEDICAL S. DE R.L. DE C.V. | Mexico | – | registered |
| OptimaT (Afdeling Huize Tordale vzw) | Belgium | – | registered |
| Oystershell NV | Belgium | – | registered |
| PHARMASPRAY BV | Netherlands | – | registered |
| PRESTIGE BRANDS HOLDINGS, INC. | United States | – | registered |
| Pentax Medical, A Division of Pentax of America, Inc. | United States | – | K190194 (2019) |
| Pentax of America, Inc. Present in Europe in other categories | United States | – | K240457 (2024) |
| Pronova Laboratories BV | Netherlands | – | K201366 (2021) |
| R2 Dermatology ,Inc | United States | – | K171398 (2017) |
| Robling Medical, LLC | United States | – | registered |
| STERIS Corporation Present in Europe in other categories | United States | – | K223369 (2022) |
| Serpex Medical | United States | – | K262420 (2026) |
| Shenzhen Kesite Digital Technology Co., Ltd. | China | – | registered |
| Theotclab Healthcare B.V. | Netherlands | – | K251524 (2026) |
| Youmedical Corp BV | Netherlands | – | K151309 (2015) |
| Yozma Bmtech Co., Ltd. | South Korea | – | K193665 (2020) |
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