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Evolvo

EUDAMED

Class IVD General (EU MDR)

Ref IKIT100

by H & D S.r.l.

Identity

Trade Name: EVOLVO EUDAMED
Device Name: EVOLVO EUDAMED
Model / Reference: IKIT100 EUDAMED

Identifiers

Primary DI / UDI-DI: 08050247770374 EUDAMED
Basic UDI-DI: B-08050247770374 EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

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

Evolvo by H & D S.r.l. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

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abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
HPLC column — Immundiagnostik AG · Class A
VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
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: H & D S.r.l.
EUDAMED SRN: IT-MF-000036620

Sources (1)

EUDAMED 7ea0ea3c-0638-4d17-8d34-88db28ff997e 61 fields · synced Jun 19, 2026