Biomate Medical Devices Technology Co., Ltd.
Active in EUDAMEDTaiwanfrom SRN EUDAMED SRN TW-MF-000002521
- Devices
- 7
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Biomate Medical Devices Technology Co., Ltd. makes
Biomate Medical Devices Technology Co., Ltd. manufactures dental implant systems and sterile acupuncture needles. The dental implant system is designed for osseointegrated tooth replacement, while the acupuncture needles are intended for traditional acupuncture procedures.
These products are regulated as Class II devices under the FDA’s 510(k) pathway. The company’s devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Bone Type Implant Ø4.8 × L10mm /RD Ref 1AA-010
Regimes: CE MDD Registry: EUDAMEDHealing Abutment D5.0H5.0 /RD Ref 1AA-205
Regimes: CE MDD Registry: EUDAMEDBioSmart Healing Abutment Ø5.5×5.0 /RD Ref BSABHL55503RA
Regimes: CE MDD Registry: EUDAMEDBioSmart Final Drill Ø4.0L10 /RD Ref BSSIFD40100RA
Regimes: CE MDD Registry: EUDAMEDBiomate Dental Implant System Ref K142174
Regimes: 510(k) Registry: 510(k)Biomate Dental Implant System Ref K170732
Regimes: 510(k) Registry: 510(k)Biomate Sterile Acupuncture Needle Ref K103061
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- TW-MF-000002521
- EUDAMED status
- Active
- EUDAMED registered name
- Biomate Medical Devices Technology
- EUDAMED abbreviated name
- Biomate Medical Device
- Registered address
- 1F, No. 59, Luke 2nd Rd., Luzhu Dist., 821, Kaohsiung City, Taiwan
- [email protected]
- PRRC contact
- Yu-Jung Su
Frequently asked questions
How many devices does Biomate Medical Devices Technology Co., Ltd. have in the registry?
The registry currently lists 7 devices for Biomate Medical Devices Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biomate Medical Devices Technology Co., Ltd.'s devices?
Among its 7 most recently registered devices, Biomate Medical Devices Technology Co., Ltd. has devices listed in EUDAMED (4 devices) and FDA 510(k) (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Biomate Medical Devices Technology Co., Ltd.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Biomate Medical Devices Technology Co., Ltd.'s devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biomate Medical Devices Technology Co., Ltd. in the registry?
The most recently registered devices listed for Biomate Medical Devices Technology Co., Ltd. include Bone Type Implant Ø4.8 × L10mm /RD, Healing Abutment D5.0H5.0 /RD, BioSmart Healing Abutment Ø5.5×5.0 /RD and BioSmart Final Drill Ø4.0L10 /RD.