MagPure RNA Kit

EUDAMED

Class A (EU MDR)

Ref HBMP-R/96Model HBMP-R/96: 16 Tests/ Kit, 96 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9600-T1: 16 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9601: 16 Tests/ Kit, 192 Tests/ Kit

by Chaozhou Hybribio Biochemistry Ltd.

Identity

Device Name: MagPure RNA Kit EUDAMED
Model / Reference: HBMP-R/96: 16 Tests/ Kit, 96 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9600-T1: 16 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9601: 16 Tests/ Kit, 192 Tests/ Kit EUDAMED
HBMP-R/96 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942221703664 EUDAMED
Basic UDI-DI: 69422217HBMPR96NORA96E5 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: Netherlands 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

MagPure RNA Kit by Chaozhou Hybribio Biochemistry Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

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Also classified as Nucleic acid extraction/isolation kit IVD.

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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	69422217HBMPR96NORA96E5	Class A	Active

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Manufacturer

Manufacturer: Chaozhou Hybribio Biochemistry Ltd.
EUDAMED SRN: CN-MF-000023818
Authorised Representative: Kingsmead Service B.V. NL-AR-000002066

Sources (1)

EUDAMED 603b8b68-6990-4db0-b35f-2f249a8dbedb 61 fields · synced Jul 18, 2026