Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry)

by Xiamen Spacegen Co., Ltd. EUDAMED

Active European Union

Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDD	NumberB-06972665704019 Basic UDI-DI	Date13 Sep 2022Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference: Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

Primary DI / UDI-DI: 06972665704019
Basic UDI-DI: B-06972665704019
EMDN Code: W010699 Genetic tests - other

Device Class: Class IVD General
Market of Registration: Netherlands

Manufacturer details

EUDAMED SRN: CN-MF-000018018
Authorised representative: Lotus NL B.V. NL-AR-000000121

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Properties

Reagent

Other properties (9)

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