Collaborative Care Diagnostics Llc Dba Biomedix
860 Blue Gentian Rd Ste 195, Eagan, MN, US
Registered product codes
2 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002619777.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 9, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 9, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗21 CFR 801.40(a)Form of a unique device identifier
121 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
1ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
1ISO 13485:2016 Clause 7.3.9Review of design and development do not include evaluation of change effects
1
- 21 CFR 801.40(a)Feb 9, 2026
Form of a unique device identifier
- 21 CFR 830.300(a)Feb 9, 2026
Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.1Feb 9, 2026
Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.9Feb 9, 2026
Review of design and development do not include evaluation of change effects
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.