Instruments for functional explorations and therapeutic interventionsGeneral medicine instrumentsGeneral medicine therapeutic treatment instruments
Body thermoregulation equipment
EMDN code Z12040208
Manufacturers registered in Europe (EUDAMED) 35
- 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) 70
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 |
|---|---|---|---|
| The Surgical Company International B.V. | Netherlands | Mistral-Air Mistral Air Mistral-Air® | K101705 (2010) |
| Jiangmen Dacheng Medical Equipment Co., Ltd. | – | IOB KoZee Warming Blanket FilteredFlo Warming Blanket IOB Warming Unit KoZee Warming Unit FilteredFlo Warming Unit | registered |
| INSPIRATION HEALTHCARE LIMITED | United Kingdom | Koala Alpha CosyTherm TraumaTherm AlphaPlus | K140078 (2014) |
| Iob Medical, Inc. | United States | IOB | K232638 (2023) |
| SOURCEMARK, LLC. | – | SourceMark Kozee | registered |
| Augustine Temperature Management, LLC | United States | Hillrom powered by Augustine Surgical HD Hot Dog Patient Warming System Controller Refurbished Equipment Hot Dog Patient Warming System Multifunction Controller Demo Equipment HotDog Temperature Management System Hot Dog Patient Warming System Demo Equipment Hot Dog Patient Warming System Multifunction Controller | K232627 (2024) |
| PRESTIGE AMERITECH, LTD. | United States | PremierPro | registered |
| Belmont Instrument Corp. | United States | CritiCool Mini ThermoWrap™ Universal 135-152cm, (single) ThermoWrap™ Universal, 104–122cm (single) CureWrap™ Pediatric, 79-91cm (8 pack) ThermoWrap™ Infant, 2.5–4.0Kg,(single) ThermoWrap™ Universal, Adults, 168-180cm, (single) | registered |
| Solventum US LLC Present in Europe in other categories | United States | Solventum™ Bair Hugger™ | registered |
| Covidien, LLC Present in Europe in other categories | United States | WarmTouch | K131361 (2013) |
| STRYKER CORPORATION Present in Europe in other categories | United States | Altrix Temperature Management Wraps Mul-T-Blanket Rapr-Round | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | MEDLINE Medline Industries, Inc. | K231211 (2023) |
| Adroit Medical Systems, Inc. | United States | Soft Air | K073712 (2008) |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| R.G. ENTERPRISES (U.S.A.), INC. | United States | Medical Warming Systems Geratherm Medical Warming Systems | K051336 (2006) |
| VITA HEAT MEDICAL | United States | Patient Warming Mattress VitaHEAT UB3 Patient Warming System - AC Power Battery Power Subassembly AC Power Adapter Subassembly Kit Battery Charger Battery | K132454 (2013) |
| STERIS Corporation Present in Europe in other categories | United States | STERIS | K200446 (2020) |
| XODUS MEDICAL, INC. Present in Europe in other categories | United States | 40671 Hot Pink Pad XL - with Arm Protectors 40670 Hot Pink Pad Controller (Assembled) 40672 Hot Pink Pad XL 40673 Hot Pink Pad EXT - with Arm Protectors 40674 Hot Pink Pad EXT | K260903 (2026) |
| Encompass Group, L.L.C. | United States | Nova | K203085 (2020) |
| M.T.R.E. ADVANCED TECHNOLOGIES LTD. | – | CritiCool Pro | registered |
| O&M HALYARD, INC. | United States | Halyard | registered |
| Avacore Technologies, Inc. | United States | warmUP | K023934 (2003) |
| BCG MEDICAL, LLC | United States | Opt-Shield Opt-Shield Air Supine | K162562 (2017) |
| Medtronic, Inc. Present in Europe in other categories | United States | – | registered |
| Molnlycke Health Care Us, LLC Present in Europe in other categories | United States | Barrier® EasyWarm® | K232508 (2023) |
| PINTLER MEDICAL, LLC | United States | Pintler Patient Warming System | K113705 (2012) |
| TEC COM GmbH, Gesellschaft für Technik, Technologie und Vermarktung | – | – | registered |
| Tec Com Medizintechnik GmbH | Germany | TECOtherm | registered |
| WELKINS, LLC | United States | Welkins | K121720 (2012) |
| 15445361 Canada Inc. | Canada | – | registered |
| 3t Medical Systems, LLC | United States | – | registered |
| AIM B.V. | Netherlands | – | registered |
| Accumed Intl., Inc. | United States | – | registered |
| Ag Marketing & Development Group Inc Dba Agmd Group | Canada | – | registered |
| Amphenol Critical Medical Technologies, LLC | United States | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| Betacera Inc. | China | – | registered |
| Braincool AB | Sweden | – | K232844 (2023) |
| C.R. Bard, Inc. | United States | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COPIOUS INTL., INC. | China | – | registered |
| Caremed Supply, Inc. Present in Europe in other categories | Taiwan | – | registered |
| Creanova doo | Serbia | – | registered |
| DSV Contract Logistics | Mexico | – | registered |
| Dielectrics, Inc. | United States | – | registered |
| Hadleigh Health Technologies Present in Europe in other categories | United States | – | K242964 (2025) |
| ITEK | Costa Rica | – | registered |
| J. STERLING INDUSTRIES LTD. | Canada | – | registered |
| JIANGYIN SINBON ELECTRONICS CO LTD | China | – | registered |
| Jabil Inc. | United States | – | registered |
| Jiangyin PureMED Products CO., Ltd. | China | – | registered |
| KEY TRONIC CORP. | United States | – | registered |
| Mainline Medical Dental Supply | Canada | – | registered |
| Minnetronix Medical, Inc. | United States | – | registered |
| Mt. Olive Mfg., Co. | United States | – | registered |
| Nortech Systems, Inc. | United States | – | registered |
| ORTA MEDICAL LTD | Israel | – | registered |
| Polimeros Formula de Tecate, SA de CV | Mexico | – | registered |
| R. H. Electronics Ltd. | Israel | – | registered |
| SINO PROTECTION INDUSTRIAL LTD. | Hong Kong SAR China | – | registered |
| Sanicure BV | Netherlands | – | registered |
| Scanfil Atvidaberg AB | Sweden | – | registered |
| Smiths Medical Asd, Inc. | United States | – | K181699 (2018) |
| Stryker Medical Present in Europe in other categories | United States | – | K180834 (2018) |
| The Surgical Company International B.V., doing business as TSC Life | Netherlands | – | K261437 (2026) |
| The Surgical Company International BV (As the 37company) | Netherlands | – | K171234 (2017) |
| Valuepack B.V. | Netherlands | – | registered |
| Wear Tex S. de R.L. de C.V. | Mexico | – | registered |
| Xodus Medical Shanghai | China | – | registered |
| ZOLL Medical Corporation Present in Europe in other categories | United States | – | registered |
Didn't find it?
Tell us what you are looking for. Requests show us which categories to add first.
Related categories
- Phototherapy equipment42 manufacturers
- General medicine therapeutic treatment instruments - medical device software40 manufacturers
- General medicine therapeutic treatment instruments - other29 manufacturers
- Dermal regeneration equipment18 manufacturers
- General medicine therapeutic treatment instruments - software accessories17 manufacturers
- Ultrasonic nebulisers17 manufacturers
- Portable microinfusion instruments14 manufacturers
- Multi-district oncological therapy instruments (excluding radiotherapy)12 manufacturers
- Liposuction systems12 manufacturers
- Photoepilation equipment12 manufacturers
- General medicine therapeutic treatment instruments - hardware accessories11 manufacturers
- Vacuum medication equipment7 manufacturers
- Parent category : General medicine therapeutic treatment instruments176 manufacturers