Home›USA›KORU MEDICAL SYSTEMS, INC.
KORU MEDICAL SYSTEMS, INC.
USA · Mahwah
✓ Record-verifiedregistrations found in 6 markets
This company has registrations in United States, Canada, Taiwan, Australia, Hong Kong, Israel — 6 overseas markets. The China NMPA lookup is still pending.
Registrations by market
Each market counts a different unit; figures are not directly comparableCNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 10 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
4 including historic records
TWTaiwanTFDA
4valid device licences
Class II 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IIa 3
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.
Australia, Hong Kong, Israel: under each source's terms, this site shows record counts and official links only — no record details on pages, in search, in the member area or in exports.
How these numbers were verified
record-verifiedCompany-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
United States10 registration records, 5 510(k), 0 PMA
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: KORU MEDICAL SYSTEMS, INC. · KORU MEDICAL SYSTEMS INC.
Same-named companies — This database also contains companies with near-identical names: Repro-Med Systems, Inc. Dba Koru Medical Systems, Repro-Medical System, Inc., Dba Koru Medical Systems. Company name alone cannot separate their registrations, so the figures below may include either.
Company information
- Country
- USA
- City
- Mahwah
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
Business registration
- CIK
- 0000704440
- Registration status
- Active
- Listing status
- Listed (KRMD)
Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.
FDA 510(k) clearances by year
22021 · K200176
12022 · K214045
12023 · K231918
12026 · K252015
FDA listed device types
Immunoglobulin G (Igg) Infusion System 1Pump, Infusion 1Set, Administration, Intravascular 1
Registration details (sample)
| Market | Identifier | Name | Class / date |
|---|
| US | K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing | 2026-01-28 |
| US | K231918 | Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter | 2023-11-03 |
| US | K214045 | FreedomEdge Syringe Infusion System | 2022-04-29 |
| CA | 79676 | RES-Q-VAC HAND HELD MEDICAL SUCTION KITS | Class II |
| CA | 79807 | RES-Q-VAC HAND HELD MEDICAL SUCTION CATHETERS | Class II |
| CA | 79808 | RES-Q-VAC HAND HELD MEDICAL SUCTION REPLACEMENT KITS | Class II |
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