Nucleic Acid Extraction Kit

EUDAMED

Class A (EU MDR)

Ref BH002

by Shandong Bohong Gene Technology Co., Ltd.

Identity

Trade Name: Nucleic Acid Extraction Kit EUDAMED
Device Name: Nucleic Acid Extraction Kit EUDAMED
Model / Reference: BH002 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974901971339 EUDAMED
06974901971308 EUDAMED
06974901970349 EUDAMED
06974901970684 EUDAMED
06974901970332 EUDAMED
06974901970172 EUDAMED
06974901970288 EUDAMED
06974901970189 EUDAMED
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06974901971322 EUDAMED
06974901970110 EUDAMED
06974901971315 EUDAMED
06974901970141 EUDAMED
06974901970318 EUDAMED
06974901970301 EUDAMED
06974901970165 EUDAMED
06974901970264 EUDAMED
06974901973050 EUDAMED
06974901972527 EUDAMED
06974901972985 EUDAMED
06974901972688 EUDAMED
06974901972978 EUDAMED
06974901972893 EUDAMED
06974901972909 EUDAMED
06974901972954 EUDAMED
06974901972510 EUDAMED
06974901972619 EUDAMED
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06974901973029 EUDAMED
06974901973005 EUDAMED
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06974901972435 EUDAMED
06974901973036 EUDAMED
06974901973012 EUDAMED
06974901972503 EUDAMED
06974901972411 EUDAMED
06974901972428 EUDAMED
06974901972725 EUDAMED
06974901972572 EUDAMED
06974901972442 EUDAMED
06974901972671 EUDAMED
06974901972749 EUDAMED
06974901973043 EUDAMED
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06974901972787 EUDAMED
06974901972855 EUDAMED
06974901972473 EUDAMED
06974901972763 EUDAMED
06974901973067 EUDAMED
06974901972923 EUDAMED
06974901972664 EUDAMED
06974901972930 EUDAMED
Basic UDI-DI: 6974901BH002TY EUDAMED
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class: Class A EUDAMED
Market of Registration: Germany 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

Nucleic Acid Extraction Kit by Shandong Bohong Gene Technology Co., Ltd. — Class A — IVDR — 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
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
Pathogen DNA/RNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., 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	6974901BH002TY	Class A	Active

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Manufacturer

Manufacturer: Shandong Bohong Gene Technology Co., Ltd.
EUDAMED SRN: CN-MF-000025971
Authorised Representative: Luxus Lebenswelt GmbH DE-AR-000005110

Sources (54)

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