MagaBio plus Virus DNA / RNA Purification Kit Ⅱ

EUDAMEDFDA UDI

Class A (EU MDR)

Ref BSC71T1SModel BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T

by Hangzhou Bioer Technology Co., Ltd.

Identity

Trade Name: MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMED
BIOER MagaBio plus Virus DNA/RNA Purification Kit II FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: MagaBio plus Virus DNA / RNA Purification Kit Ⅱ EUDAMED
For the detail information, please refer to the IFU. FDA UDI
Model / Reference: BSC71T1S, BSC71S1S, BSC71M1S,BSC71L1S, BSC71T1E,BSC71S1E, BSC71M1E, BSC71L1E, BSC71T1C, BSC71S1C, BSC71S1B, BSC71M1B, BSC71M1E-T, BSC71L1E-T EUDAMED
BSC71T1S EUDAMEDFDA UDI
Description: For the detail information, please refer to the IFU. FDA UDI

Identifiers

Primary DI / UDI-DI: 06973843226347 EUDAMED
06973843228037 FDA UDI
Basic UDI-DI: 697384322BSC71HU EUDAMED
Direct Marketing DI: 06973843226347 EUDAMED
FDA Product Code: JJH FDA UDI
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class A EUDAMED
Class I FDA UDI
Regulation Number: 862.2310 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

MagaBio plus Virus DNA / RNA Purification Kit Ⅱ by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

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 (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697384322BSC71HU	Class A	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class A	Pending data

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Manufacturer

Manufacturer: Hangzhou Bioer Technology Co., Ltd.
EUDAMED SRN: CN-MF-000019512
Authorised Representative: MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

EUDAMED 23583b6c-6040-4192-8b66-5523b4e83d68 61 fields · synced Jul 10, 2026
FDA UDI a268d3eb-e07f-4771-83b0-db5e311de312 33 fields · synced May 30, 2026