Apheresis devicesApheresis therapy devices
Extracorporeal photochemotherapy or photopheresis devices and kits
EMDN code B030204
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 |
|---|---|---|---|---|
| Maco Pharma FDA | France |
|
IIa, IIb 93/42 | eudamed@macopharma.com EUDAMED record Report an error |
| Therakos FDA | Ireland | IIa MDR | Website regulatory@therakos.com 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) 2
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 |
|---|---|---|---|
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| MACK MOLDING COMPANY | United States | – | registered |
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