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Snapshot 2026-10-11 · Link to EUDAMED

Legacy device

High-Flo Subcutaneous Safety Needle Sets

UDI-DI 00659443000322Basic UDI-DI B-00659443000322

Class IIa · MDD (legacy) · KORU Medical Systems, Inc

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Identification

Model: High-Flo Subcutaneous Safety Needle Sets
EMDN: A010199
Issuing agency: GS1
Device status: active
Sterile: Yes
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

KORU Medical Systems, Inc

SRN US-MF-000025369

US · Mahwah, New Jersey

manufacturer

Authorised representative: ICON (LR) Limited (IE-AR-000006507)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/high-flo-subcutaneous-safety-needle-sets-0322 · UDI page: /udi/00659443000322

All devices from KORU Medical Systems, Inc

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