EU → North America Device Access

CHIRANA T.Injecta, a.s.

SK-MF-000003702 · Slovakia · Stará Turá

CHIRANA T.Injecta, a.s. is registered in the European database on medical devices as a manufacturer, with 97 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa96
Class IIb1

Most frequent device types declared: Bed cover, Blood collection needle, Blood collection needle holder, Filter, Hypodermic syringe.

Among these devices, 86 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 97 declared devices.

Catalogue references include 20010, AP02-001-00/CH, CH010L, CH03050LLO, CH700040, CHBC01.

European nomenclature codes declared: A01010502, A020102020102, A020102010202, A020102010102, A0101010102, A0101010202.

United States market access

FDA establishment registerRegistered with FDA
Matched entryCHIRANA T.INJECTA, A.S. (SK) · FDA 3008272066
Devices in EUDAMED97
Country of registrationSlovakia

Device-level evidence

Devices with a numeric GTIN97
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: United States only. CHIRANA T.Injecta, a.s. is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
2024-MDR/QS-071issued2027-09-30
2022-MDR/QS-027/Asupplemented2027-09-30
2022-MDR/QS-026/Dsupplemented2027-09-30
2022-MDR/QS-025/Esupplemented2027-09-30
2022-MDR/QS-024/Bsupplemented2027-09-30

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