Healstone Biotech, Inc.
Active in EUDAMEDCanadafrom SRN EUDAMED FDA SRN CA-MF-000057743
- Devices
- 41
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Healstone Biotech, Inc. makes
Healstone Biotech, Inc. manufactures over-the-counter and prescription urine drug testing cups, including single-panel and multi-panel tests for detecting drugs of abuse, as well as a one-step pregnancy test for home use.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 41 devicesCompany details
- EUDAMED SRN
- CA-MF-000057743
- EUDAMED status
- Active
- EUDAMED registered name
- HEALSTONE Biotech Inc.
- Registered address
- 655 W Kent North, Unit 650, V6P6T7, Vancouver BC, Canada
- [email protected]
- PRRC contact
- Joyce Pang
FDA establishments
- Healstone Biotech Inc. Vancouver British Columbia · CA FEI 3014301129
Frequently asked questions
How many devices does Healstone Biotech, Inc. have in the registry?
The registry currently lists 41 devices for Healstone Biotech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healstone Biotech, Inc.'s devices?
Among its 41 most recently registered devices, Healstone Biotech, Inc. has devices listed in EUDAMED (38 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 Healstone Biotech, Inc.'s devices fall under?
Among its 41 most recently registered devices, the classes recorded for Healstone Biotech, Inc.'s devices are Class II and IVD general. Each device page shows its own class and authorisation.
What are the newest devices from Healstone Biotech, Inc. in the registry?
The most recently registered devices listed for Healstone Biotech, Inc. include Urinalysis Strips, CARBA 5 In 1 Rapid Test Cassette, Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) and Zika NS1 Ag Rapid Test Cassette (Whole blood/Serum/Plasma).
Which FDA establishments are linked to Healstone Biotech, Inc.?
1 FDA establishment is linked to Healstone Biotech, Inc. in the registry; they are listed on the company page.