Magnetic Circulating DNA Maxi Kit

by Beijing OriginPoly Bio-Tec Co., Ltd. 3 variants

Ref 12 tests/kitModel (12 tests), (24 tests), (48 tests)

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number697513967OPBT0083R Basic UDI-DI 06975139678113UDI-DI	Date30 Aug 2024Registered	StatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name: Magnetic Circulating DNA Maxi Kit
Model / Reference: (12 tests), (24 tests), (48 tests), 12 tests/kit

Primary DI / UDI-DI: 06975139678113
Basic UDI-DI: 697513967OPBT0083R
EMDN Code: W0105900101 Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus

Device Class: Class A
EU market of registration: Austria

Manufacturer details

EUDAMED SRN: CN-MF-000043242
Authorised representative: SUNGO Europe B.V. NL-AR-000000247

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Properties

Reagent
Professional Testing

Other properties (9)

Sterile: No
Human Tissues: No
Animal Tissues: No
Microbial Substances: No
Self Testing: No
Near-Patient Testing: No
Companion Diagnostics: No
Surgical Instrument: No
New Device: No