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halosperm G2 PRO

EUDAMED

Class IVD General (EU MDR)

Ref HT-HSG2P

by Halotech DNA

Identity

Trade Name: halosperm G2 PRO EUDAMED
Device Name: halosperm G2 PRO EUDAMED
Model / Reference: HT-HSG2P EUDAMED

Identifiers

Primary DI / UDI-DI: 08437024427094 EUDAMED
Basic UDI-DI: B-08437024427094 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

halosperm G2 PRO 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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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 cff5122a-48ef-4698-b32e-19af86f16d6c 61 fields · synced Jul 16, 2026