Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsVarious instruments for general and multidisciplinary surgery
Thawing units
EMDN code Z12019009
Manufacturers registered in Europe (EUDAMED) 2
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| Barkey FDA | Germany |
|
IIa MDR | Website info@barkey.de EUDAMED record Report an error |
| Kaltek | Italy | I MDR | info@kaltek.it EUDAMED record Report an error |
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) 14
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 |
|---|---|---|---|
| ICU MEDICAL, INC. Present in Europe in other categories | United States | Level 1 bcI | registered |
| CYTOTHERM LP | – | CytoTherm | registered |
| Sarstedt Aktiengesellschaft & Co.KG | – | SAHARA-III MAXITHERM 115V SAHARA-TSC 115V SAHARA-III basic model 115V | registered |
| Transmed Medizintechnik GmbH & Co. KG | – | SAHARA | registered |
| AnalytiChem USA, Inc. | United States | Redipor | registered |
| BOEKEL INDUSTRIES, INC. | United States | Boekel Plasma Thawer | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| FREMON SCIENTIFIC, INC. Present in Europe in other categories | United States | ZipThaw™ 202 | registered |
| ADVANCED SCIENTIFICS, INC. | United States | – | registered |
| Boekel Scientific | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| Minnetronix Medical, Inc. | United States | – | registered |
| SARSTEDT, INC. Present in Europe in other categories | United States | – | registered |
| Terumo BCT, INC. Present in Europe in other categories | United States | – | registered |
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