Data / Medical devices / Adjunctive Cardiac Amyloidosis Status Indicator
Adjunctive Cardiac Amyloidosis Status Indicator (SDJ): 3 FDA-registered makers in 3 countries
3 establishments in 3 countries are registered with the FDA to make Adjunctive Cardiac Amyloidosis Status Indicator (product code SDJ, Class 2, 21 CFR 870.2200). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on June 20, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- SDJ
- Device class
- 2
- Regulation
- 870.2200
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| Singapore | 1 |
| United States | 1 |
| United Kingdom | 1 |
Makers of Adjunctive Cardiac Amyloidosis Status Indicator
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Eko.ai Pte. Ltd. | Singapore Central Singapore, Singapore | Manufacturer | 1 | June 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Invision Medical Technology | Sunnyvale, CA, United States | Manufacturer | 1 | May 21, 2025 | 0 | 0 | 0 | api.fda.gov |
| Ultromics, Ltd. | Oxford Oxfordshire, United Kingdom | Complaint file establishment, Manufacturer | 1 | November 15, 2024 | 0 | 0 | 0 | api.fda.gov |
Updated June 20, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.