Hycare International Co., Ltd.
Active in EUDAMEDThailandfrom SRN EUDAMED FDA SRN TH-MF-000012195
- Devices
- 21
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
- Authorised rep.
- MedNet EC-REP GmbHDE
What Hycare International Co., Ltd. makes
Hycare International Co., Ltd. manufactures examination gloves, including nitrile, latex, and powder-free variants designed for medical and clinical use. Their product line includes branded gloves like Hycare Med+, Hycare Touch, Hycare Sense, and Dr. Mayer, as well as generic CMT examination gloves. These gloves are intended for single-use in healthcare settings to reduce contamination risk during procedures.
The company’s examination gloves fall under Class I medical devices and are listed in the EUDAMED registry and the FDA’s 510(k) database. The manufacturer is based in Thailand.
Catalogue
Search and filter all 21 devicesCompany details
- EUDAMED SRN
- TH-MF-000012195
- EU VAT number
- 0105536002944
- EUDAMED status
- Active
- EUDAMED registered name
- Hycare International Co.,Ltd.
- EUDAMED abbreviated name
- HCI
- Registered address
- Asia Highway, 90110, Songkhla Thailand, Thailand
- [email protected]
- Phone
- +6674552654-6
- PRRC contact
- Kevin Gostner
FDA establishments
- Hycare International Co., Ltd. Unknown
Frequently asked questions
How many devices does Hycare International Co., Ltd. have in the registry?
The registry currently lists 21 devices for Hycare International Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hycare International Co., Ltd.'s devices?
Among its 21 most recently registered devices, Hycare International Co., Ltd. has devices listed in EUDAMED (20 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hycare International Co., Ltd.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Hycare International Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Hycare International Co., Ltd. in the registry?
The most recently registered devices listed for Hycare International Co., Ltd. include Hycare Sense Examination gloves, CMT Examinationa Gloves, Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves and CMT Examination Gloves.
Which FDA establishments are linked to Hycare International Co., Ltd.?
1 FDA establishment is linked to Hycare International Co., Ltd. in the registry; they are listed on the company page.