Fitone Latex Products Co., Ltd. Guangdong
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000012805
- Devices
- 25
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
What Fitone Latex Products Co., Ltd. Guangdong makes
The company manufactures single-use natural rubber latex male condoms in various formulations, including smooth ultra-thin variants, and a range of sterile latex surgical gloves in multiple sizes. These products are designed for medical, contraceptive, and protective applications, adhering to latex-based standards for barrier protection.
The portfolio includes devices classified as Class IIa and Class IIb under EU regulations, with all relevant products registered in the euDAMED database. The manufacturer is based in Guangdong, China.
Catalogue
Search and filter all 25 devicesCompany details
- EUDAMED SRN
- CN-MF-000012805
- EU VAT number
- 9144082358141151XJ
- EUDAMED status
- Active
- EUDAMED registered name
- FITONE LATEX PRODUCTS CO., LTD. GUANGDONG
- Registered address
- No.5, No.5 Tongyi Road, Lingbei Industrial Zone, Suixi, 524338, Zhanjiang, Guangdong, China
- [email protected]
- Phone
- +86 759 2728169
- PRRC contact
- SHIWU XIAO
Frequently asked questions
How many devices does FITONE LATEX PRODUCTS CO., LTD. GUANGDONG have in the registry?
The registry currently lists 25 devices for FITONE LATEX PRODUCTS CO., LTD. GUANGDONG. Devices recorded under merged duplicate company entries are counted once.
Which registries list FITONE LATEX PRODUCTS CO., LTD. GUANGDONG's devices?
Among its 25 most recently registered devices, FITONE LATEX PRODUCTS CO., LTD. GUANGDONG has devices listed in EUDAMED (21 devices) and FDA 510(k) (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do FITONE LATEX PRODUCTS CO., LTD. GUANGDONG's devices fall under?
Among its 25 most recently registered devices, the classes recorded for FITONE LATEX PRODUCTS CO., LTD. GUANGDONG's devices are Class I, Class IIa and Class IIb. Each device page shows its own class and authorisation.
What are the newest devices from FITONE LATEX PRODUCTS CO., LTD. GUANGDONG in the registry?
The most recently registered devices listed for FITONE LATEX PRODUCTS CO., LTD. GUANGDONG include POLMIL, Fitone Natural Rubber Latex Probe Covers, Sterile Single-use Medical Latex Examination Gloves and Fitone Medical Nitrile Examination Gloves.