Regulation
For medical devices, reliability starts with being listed in the official registries of the markets where the product is sold. CranioWell products are UTS-registered; our baby ear corrector is also listed in EUDAMED.
These systems support traceability from manufacturing to the patient and are overseen by health authorities.
CranioWell products are registered in UTS. Because our baby ear corrector is sold in Europe, it is also registered in EUDAMED.
| Feature | UTS (Türkiye) | EUDAMED (EU) | FDA (USA) |
|---|---|---|---|
| Legal basis | Turkish Medical Device Regulation (EU MDR-aligned) | EU MDR 2017/745 | Federal Food, Drug and Cosmetic Act |
| Scope | Devices sold in Türkiye | Devices sold in the EU | Devices for the US market |
| Approx. registrations | 518,000 devices | Hundreds of thousands (modules rolling out) | 175,000 devices |
| Purpose | Traceability, patient safety | Safety, performance, transparency | Safety and effectiveness review |
| Foreign devices | Required for sale in Türkiye | Required for sale in the EU | Required for sale in the US |
| Ear corrector set | UTS registered | EUDAMED registered | Not started yet |
| HKM Pro helmet | UTS registered | Registration planned | Not started yet |
FDA oversight applies to the US market. An “FDA-approved” claim alone does not mean a device may be sold in Türkiye or the EU. Sale in Türkiye requires UTS registration; sale in the EU requires EUDAMED registration.
We treat UTS, EUDAMED and FDA pathways as complementary, not interchangeable. Local manufacturing and regional registration duties are handled together, with traceability and compliance prioritized for infant-care devices.
