Fuzhou Rick Brown Biomaterials Co. Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000033940 FEI 3029968429
- Devices
- 196
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
What Fuzhou Rick Brown Biomaterials Co. Ltd. makes
Fuzhou Rick Brown Biomaterials Co. Ltd. specializes in ceramic materials designed for dental appliance fabrication, including products used in dental restorations and prosthetics. Their portfolio includes a range of materials branded under Dentitude, which are intended for creating durable and biocompatible dental components.
The company’s products fall under FDA Class II medical devices and are authorised through the 510(k) and De Novo pathways. These materials are registered with the FDA’s Unique Device Identification (UDI) system, ensuring traceability and compliance with US regulatory standards. The manufacturer operates from the United States.
Catalogue
Search and filter all 196 devicesShowing 1-50 of 196
Company details
- EUDAMED SRN
- CN-MF-000033940
- FDA FEI number
- 3029968429
- DUNS number
- 416486948
- EUDAMED status
- Active
- EUDAMED registered name
- Fuzhou Rick Brown Biomaterials Co., Ltd.
- Registered address
- The first and second floors of R&D Building, Jiecheng Industrial Park, No.36 Houshan Zhaishan, Nanyu Town, High-Tech District, Fuzhou, 350100, Fuzhou, China
- [email protected]
- Phone
- +86 591 23507151
- PRRC contact
- Honglin Liu
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 17 Nov 2029
UDEM Adriatic d.o.o. 2696 1 certificate
- M.2024.MDR.1056 Active
Quality management system EU MDR
- Issued
- 18 Nov 2024
- Expires
- 17 Nov 2029
Frequently asked questions
How many devices does Fuzhou Rick Brown Biomaterials Co. Ltd. have in the registry?
The registry currently lists 196 devices for Fuzhou Rick Brown Biomaterials Co. Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fuzhou Rick Brown Biomaterials Co. Ltd.'s devices?
Among its 50 most recently registered devices, Fuzhou Rick Brown Biomaterials Co. Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Fuzhou Rick Brown Biomaterials Co. Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Fuzhou Rick Brown Biomaterials Co. Ltd.'s devices are Class IIa. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Fuzhou Rick Brown Biomaterials Co. Ltd.?
EUDAMED lists 1 certificate for Fuzhou Rick Brown Biomaterials Co. Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 18 Nov 2024.
What are the newest devices from Fuzhou Rick Brown Biomaterials Co. Ltd. in the registry?
The most recently registered devices listed for Fuzhou Rick Brown Biomaterials Co. Ltd. include Dental Lithium Disilicate Glass-Ceramic.