EU → US Device Access

Herb-Pharma Corporation s.r.o.

SK-MF-000005839 · Slovakia · Velke Ludince

Herb-Pharma Corporation s.r.o. is registered in the European database on medical devices as a manufacturer, with 21 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa16
Class IIb5

Most frequent device types declared: 02023, 14008, 14007.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationSlovakia
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
2026-MDR/QS-010/Asupplemented2029-04-18
2026-MDR/QS-009/Asupplemented2029-04-18
2025-MDR/QS-003/Asupplemented2029-04-18
2024-MDR/QS-023/Bsupplemented2029-04-18

Other manufacturers in Slovakia

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