YALEPIC® Cell-Free DNA Extraction Kit（Magbead)

EUDAMED

Class A (EU MDR)

Ref Non-prepackaged 96 tests/Box Model Non-prepackaged：96 tests/Box；Prepackaged：96 tests/Box, 48 tests/Box, 32 tests/Box.

by Yali Biotech

Identity

Device Name: YALEPIC® Cell-Free DNA Extraction Kit（Magbead) EUDAMED
Model / Reference: Non-prepackaged：96 tests/Box；Prepackaged：96 tests/Box, 48 tests/Box, 32 tests/Box. EUDAMED
Non-prepackaged 96 tests/Box EUDAMED

Identifiers

Primary DI / UDI-DI: 06978261340071 EUDAMED
Basic UDI-DI: 697826134YLCDEKWW EUDAMED
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Austria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Category: Nucleic acid extraction/isolation kit IVD

YALEPIC® Cell-Free DNA Extraction Kit（Magbead) by Yali Biotech — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
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/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697826134YLCDEKWW	Class A	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Yali Biotech
EUDAMED SRN: CN-MF-000046226
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED 448dcb7b-f4e9-4267-bd70-7c07bd704808 61 fields · synced Jul 25, 2026