Tier 1 — FDA Supplier

MedDevice Components Inc.

Vendor ID: VND-002 · FEI: 3019876543

FDA-registered component manufacturer — ECG sensor PCBs and glucose sensor electrodes for Class II devices.

Canonical URL: /vendors/meddevice-components-vnd-002.html
Vendor ID: VND-002
FDA FEI Number: 3019876543
ISO 13485: Valid to March 2028
CFR Reference: 21 CFR 820.50, 820.80

FDA Supplier Qualification

MedDevice Components Inc. is an approved supplier on the Veridian AVL per 21 CFR 820.50 for all PCB and sensor electrode components used in FDA-cleared devices.

Incoming inspection per 21 CFR 820.80 is required for 100% of lots received from MedDevice Components; sampling plans are defined in SOP-QC-012.

Any change to MedDevice's manufacturing process, facility, or materials requires prior notification to Veridian Quality Assurance and may require a design change assessment per SOP-DES-007.

ComponentPart NumberDevice510(k)Last Incoming InspectionResult
ECG Sensor PCB AssemblyMDC-ECG-4000-AVPM-4000K240847Mar 2026Pass
Glucose Sensor ElectrodeMDC-GS-200-BVGP-200K231156Mar 2026Pass
Insulin Pump Motor AssemblyMDC-IP-100-CVID-100K220893Feb 2026Pass

Quality Agreement Summary

Agreement IDVM-QA-002-2024
Signed DateMarch 1, 2024
Change Notification SLA10 business days
SCAR Response SLA15 business days
Right to AuditAnnual on-site audit permitted with 30 days notice
Last On-Site AuditFebruary 12, 2026 — 0 major findings

Related: FDA 510(k) Clearances · 21 CFR 820.50 · Vendor Policy §7.0