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SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit

EUDAMED

Class IVD General (EU MDR)

Ref ZT-MAWB-01-96Model ZT-MAWB

by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.

Identity

Trade Name: SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit EUDAMED
Device Name: Magic-Auto Whole Blood DNA/RNA Isolation Kit EUDAMED
Model / Reference: ZT-MAWB EUDAMED
ZT-MAWB-01-96 EUDAMED

Identifiers

Primary DI / UDI-DI: 08697962616343 EUDAMED
Basic UDI-DI: B-08697962616343 EUDAMED
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED

Classification

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

Clinical & Handling

Sterile

No

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

Category: Nucleic acid extraction/isolation kit IVD

SOFTEC Magic-Auto Whole Blood DNA/RNA Isolation Kit by Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

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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: Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
EUDAMED SRN: TR-MF-000046897

Sources (1)

EUDAMED fb5c734e-088c-444c-87d0-dff75cc504da 61 fields · synced Jul 13, 2026