Saladax Biomedical Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED SRN US-MF-000007957
- Devices
- 20
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- Authorised rep.
- Emergo Europe B.V.NL
Catalogue
Psychiatry Total Aripiprazole Assay Kit Ref C82913
MyCare Psychiatry Olanzapine Assay Kit Ref OLZ-RGT
My5-FU Assay Ref 5FU-RGT
Psychiatry Olanzapine Assay Kit Ref C82915
MyCare Insite Ref MCI-EUR
MyCare Psychiatry Total Aripiprazole Assay Kit Ref ARI-RGT
MyCare Insite Clozapine Test Ref CLZ-MCI-32.2
My5-FU Control Kit Ref 5FU-CON
My5-FU Calibrator Kit Ref 5FU-CAL
My5-FU Sample Stabilizer Kit Ref 5FU-STB
Beckman Coulter C82912 Ref C82912
MyCare Psychiatry MCP2-CAL Ref MCP2-CAL
Beckman Coulter C82911 Ref C82911
MyCare Psychiatry CLZ-RGT Ref CLZ-RGT
MyCare Psychiatry MCP2-CON-US Ref MCP2-CON-US
MyCare Psychiatry MCP2-CON Ref MCP2-CON
MyCare Psychiatry MCP2-CAL-US Ref MCP2-CAL-US
Beckman Coulter C82914 Ref C82914
MyCare Psychiatry Clozapine Assay Kit Ref DEN190028
MyCare Insite Total Aripiprazole Test Ref ARI-MCI-32
Company details
- EUDAMED SRN
- US-MF-000007957
- DUNS number
- 144379539
- EUDAMED status
- Active
- EUDAMED registered name
- Saladax Biomedical Inc.
- EUDAMED abbreviated name
- Saladax
- Registered address
- 116, Research Drive, 18015, Bethlehem, United States
- Website
- www.saladax.com/
- [email protected]
- Phone
- +1 (610) 419-6731
- PRRC contact
- Greg Lundell
EUDAMED certificates
1 certificate1 valid, 0 expiredIVDR 1next expiry 21 Sep 2031
Notified body 2797 1 certificate
- IVDR 748215 Issued
Quality management system EU IVDR
- Issued
- 22 Sep 2026
- Expires
- 21 Sep 2031
What Saladax Biomedical Inc. makes
Saladax Biomedical Inc. manufactures in vitro diagnostic (IVD) products for psychiatric drug monitoring, including calibrators, controls, and reagents specifically for clozapine. Their portfolio also includes assay kits and tests for measuring total aripiprazole levels, designed for laboratory use in clinical settings.
These devices are regulated under Class I and Class II classifications, with some falling under the IVD General category. They are listed in the EU’s EUDAMED registry, the FDA’s 510(k) and UDI databases, and are distributed through partners like Beckman Coulter and MyCare Psychiatry. The company operates from the United States.
Frequently asked questions
How many devices does Saladax Biomedical Inc. have in the registry?
The registry currently lists 20 devices for Saladax Biomedical Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Saladax Biomedical Inc.'s devices?
Among its 20 most recently registered devices, Saladax Biomedical Inc. has devices listed in EUDAMED (13 devices), FDA 510(k) (1 device) and FDA GUDID (8 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Saladax Biomedical Inc.'s devices fall under?
Among its 20 most recently registered devices, the classes recorded for Saladax Biomedical Inc.'s devices are Class I, Class II, IVDR Class A and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Saladax Biomedical Inc.?
EUDAMED lists 1 certificate for Saladax Biomedical Inc. (quality management system) under IVDR. 1 is recorded with the status issued. The most recent was issued on 2026-09-22.
What are the newest devices from Saladax Biomedical Inc. in the registry?
The most recently registered devices listed for Saladax Biomedical Inc. include Psychiatry Total Aripiprazole Assay Kit, MyCare Psychiatry Olanzapine Assay Kit, My5-FU Assay and Psychiatry Olanzapine Assay Kit.