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dyn-halosperm

EUDAMED

Class IVD General (EU MDR)

Ref HT-DHS5G2

by Halotech DNA

Identity

Trade Name: dyn-halosperm EUDAMED
Device Name: dyn-halosperm EUDAMED
Model / Reference: HT-DHS5G2 EUDAMED

Identifiers

Primary DI / UDI-DI: 08437024427025 EUDAMED
Basic UDI-DI: B-08437024427025 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Spain EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Nucleic acid extraction/isolation kit IVD

dyn-halosperm by Halotech DNA — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Nucleic acid extraction/isolation kit IVD.

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VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
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MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Halotech DNA
EUDAMED SRN: ES-MF-000001921

Sources (1)

EUDAMED c3f4155c-adf2-45c6-b0c7-e4e3f1573b1b 61 fields · synced Jun 18, 2026