Is this your brand? Sign in to claim ownership.
Sign in to claim this brandWhat Healux Co., Ltd makes
Healux Co., Ltd manufactures rotary dermabrasion brushes designed for skin resurfacing procedures, including the HealFusion Pro model. These devices are intended for controlled exfoliation and tissue removal in dermatological treatments.
The company’s portfolio is classified under FDA’s Class I medical devices and is listed in the FDA’s Unique Device Identifier (UDI) database. Healux Co., Ltd operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Healux Co., Ltd manufacture?
Healux Co., Ltd specializes in rotary dermabrasion brushes, specifically designed for skin resurfacing procedures. These devices are used in dermatology to perform controlled exfoliation and tissue removal, such as the HealFusion Pro model.
Where is Healux Co., Ltd based?
Healux Co., Ltd is headquartered in the United States. The company’s location is relevant for regulatory and operational purposes, as it influences compliance with U.S. medical device regulations.
Which regulatory registries or databases list Healux Co., Ltd’s devices?
Healux Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for regulatory oversight, particularly for Class I devices.
How are Healux Co., Ltd’s devices classified under FDA regulations?
Healux Co., Ltd’s devices fall under the FDA’s Class I classification. This classification is typically assigned to low-risk medical devices, such as rotary dermabrasion brushes, which require minimal regulatory controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- [email protected]
- Phone
- +82221692880
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 695821746
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HealFusion Pro | HealFusion Pro | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.