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EDTA 2Na/2K, 6-Aminohexanoic acid, Glycine G.R., DNA

EUDAMED

Class A (EU MDR)

Ref E2N2K1610007

by Hygienx Doo Beograd-Rakovica

Identity

Trade Name
EDTA 2Na/2K, 6-Aminohexanoic acid, Glycine G.R., DNA EUDAMED
Device Name
VACUUM TUBES EUDAMED
Model / Reference
E2N2K1610007 EUDAMED

Identifiers

Primary DI / UDI-DI
08606034793103 EUDAMED
Basic UDI-DI
8606110811-BLOOD-TUBE-JV EUDAMED
Direct Marketing DI
08606034793103 EUDAMED
EMDN Code
W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Croatia EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

EDTA 2Na/2K, 6-Aminohexanoic acid, Glycine G.R., DNA by Hygienx Doo Beograd-Rakovica — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hygienx Doo Beograd-Rakovica
EUDAMED SRN
RS-MF-000048020
Authorised Representative
Salus Cons Kft. HU-AR-000006177

Sources (1)

  • EUDAMED 5743113e-910e-469d-8f12-4fc8588d7647 61 fields · synced Jul 30, 2026