EU → North America 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 IIb5
Class IIa16

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

Devices declared under this manufacturer

Showing 12 of 21 declared devices.

Catalogue references include 02025, 02026, 04002, 04018, 04019, 10034.

European nomenclature codes declared: Q03040299, M9002,V9099, U0803, V9099, M9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED21
Country of registrationSlovakia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN13
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Herb-Pharma Corporation s.r.o. was not found in either the U.S. or the Canadian register.

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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