Biocetec Co., Ltd.
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000045343
- Devices
- 526
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Biocetec Co., Ltd. makes
Biocetec Co., Ltd. manufactures orthodontic ceramic brackets, including the C-Line, S-Line, and A-Line Advanced series, as well as orthodontic mini implants under the Bio-TackS brand. These products are designed for dental alignment and anchorage applications in orthodontic treatment.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance in the United States. No additional registries or classifications are specified.
Catalogue
Search and filter all 526 devicesShowing 1-50 of 526
Company details
- EUDAMED SRN
- KR-MF-000045343
- EUDAMED status
- Active
- EUDAMED registered name
- Biocetec Co., Ltd.
- Registered address
- 108, Gasandigital 2-ro (RM1001-1002 New T Castle), 08506, Seoul, South Korea
- Website
- www.biocetec.com
- [email protected]
- Phone
- +82 2 704 2876
- PRRC contact
- Heesue Jin
Frequently asked questions
How many devices does Biocetec Co., Ltd. have in the registry?
The registry currently lists 526 devices for Biocetec Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biocetec Co., Ltd.'s devices?
Among its 50 most recently registered devices, Biocetec Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Biocetec Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Biocetec Co., Ltd.'s devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from Biocetec Co., Ltd. in the registry?
The most recently registered devices listed for Biocetec Co., Ltd. include Bio-Tack, Bio-Tack S, C-Line and S-Line.