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Bgi

by Bgi Europe a/S 29 variants

Ref MFG030065, MFG010041, MFG010033, SAC2022016, SAC2022018, MFG010043, SAC2022003, MFG010031, SIGVAR, SAI2022005, MFG030058, SAC2022017, SAI2022003, SAC2022006, SAI2022014, SAC2022015, SAC2022033, EU0200050007 (PBC22 Plus), MFG010034, Sentis-PanCancer-CL, MFG010038, SAC2022030, SAI2022013, Sentis-LungCT-CL, MFG030063, SAC2022021, MFG010037, SAI2022006, EU0100110050, EU0200050005 (PBC20 Plus), SAI2022011, SAC2022034, SAC2022024, Sentis-PanCancer, MFG010019, SAC2022031, SAC2022029, EU0100030050, SAI2022001, SAC2022028, SAI2022019, SAC2022035, SAC2022001, EU0100090096, SAC2022025, EU0100150001, SAC2022005, knowliter-1, EU0100060960, MFG030015, SAC2022036Model 96 tests/kit, 50 tests/kit, 1000 tests/kit, 50 tests/kit, 400 tests/kit, 10 tests/kit, 50 tests/kit, one test per collection kit, 5 tests/kit, 120 tests/kit, 3600tests, 25 tests/kit, 96 tests/kit-A, PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus, 48 tests/kit, 1 test/kit, 48 tests, One test per self-sampling kit, 960 tests/kit

Active European Union

CE IVDR CE IVDD

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-MFG030065R2 Basic UDI-DI Date11 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-MFG030065R2 Basic UDI-DI Date11 May 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Specification

EUDAMED

Device Name
A LC-MS/MS Kit for the quantitative measurement of Trimethylamine N-oxide and its metabolism pathways in serum
Sample Pretreatment Kit for Methylation Detection
Nucleic Acid Extraction Kit
Fecal Occult Blood (FOB) Test (Colloidal Gold)
Stool Sample Collection Kit for Colorectal Cancer Testing
SIGVAR software
Glycated Hemoglobin Determination Kit（Fluorescence Immunochromatographic Assay）
Chromosomal Aneuploidy Detection Kit (Combinatorial Probe-Anchor Synthesis Sequencing Method)
Serumamyloid A Determination Kit（Fluorescence Immunochromatographic Assay）
NT-proBNP N-terminal-pro-B-type natriuretic peptide Test (Colloidal Gold)
D-Dimer Test(Colloidal Gold)
Free β Human Chorionic Gonadotropin (F-β-HCG) Test (Colloidal Gold)
Automated clinical chemistry analyzer
Solid Tumor Multi-Gene Combined Detection Analysis Software
DNA Isolation Kit
Alpha fetoprotein Test (Colloidal Gold)
Serumamyloid A Determination Kit（Fluorescence Immunochromatographic Assay
Lung Cancer Circulating Tumor DNA Multi-gene Mutation Detection Analysis Software
A LC-MS/MS Kit for the quantitative measurement of tyrosine kinase inhibitor in plasma
H. pylori Antibody Test (Colloidal Gold)
Stool Sample Collection Kit
C-reactive protein Determination Kit（Fluorescence Immunochromatographic Assay）
Cystatin Determination Kit（Fluorescence Immunochromatographic Assay）
Malaria Pan/Pf Antigen Test (Colloidal Gold)
Carcino-embryonic antigen(CEA)Test (Colloidal Gold)
Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence PCR)
PV/PF Malaria pv(pLDH)/ pf(HRPⅡ) Antigen Test (Colloidal Gold)
Nucleic Acid Extraction Kit Pro
SeqHPV Test Self-sampling Kit
KNOWLITER software
Sample Releasing Agent
Real-time fluorescent RT-PCR kit for detecting SARS-CoV-2
Model / Reference
96 tests/kit, MFG030065, 50 tests/kit, 1000 tests/kit, MFG010041, 400 tests/kit, MFG010033, 10 tests/kit, SAC2022016, SAC2022018, one test per collection kit, MFG010043, 5 tests/kit, SAC2022003, 120 tests/kit, 3600tests, MFG010031, SIGVAR, 25 tests/kit, SAI2022005, 96 tests/kit-A, MFG030058, SAC2022017, SAI2022003, SAC2022006, SAI2022014, SAC2022015, SAC2022033, PBC20， PBC20A， PBC22， PBC22A，PBC20 Plus, PBC20A Plus，PBC22 Plus，PBC22A Plus, EU0200050007 (PBC22 Plus), MFG010034, Sentis-PanCancer-CL, MFG010038, SAC2022030, SAI2022013, Sentis-LungCT-CL, 48 tests/kit, MFG030063, SAC2022021, 1 test/kit, MFG010037, SAI2022006, EU0100110050, EU0200050005 (PBC20 Plus), SAI2022011, SAC2022034, SAC2022024, Sentis-PanCancer, 48 tests, MFG010019, SAC2022031, SAC2022029, EU0100030050, SAI2022001, SAC2022028, SAI2022019, SAC2022035, SAC2022001, EU0100090096, SAC2022025, One test per self-sampling kit, EU0100150001, SAC2022005, knowliter-1, 960 tests/kit, EU0100060960, MFG030015, SAC2022036
Primary DI / UDI-DI
D-MFG030065R2, 05745000468287, 05745000468195, D-SAC2022016ED, D-SAC2022018EH, 05745000468294, D-SAC2022003E4, 05745000468225, D-SIGVARNZ, D-SAI2022005HS, D-MFG030058R5, D-SAC2022017EF, D-SAI2022003HN, D-SAC2022006EA, D-SAI2022014HT, D-SAC2022015EB, D-SAC2022033ED, 05745000468478, 05745000468201, D-Sentis-PanCancer-CLAD, 05745000468256, D-SAC2022030E7, D-SAI2022013HR, D-Sentis-LungCT-CL5D, D-MFG030063QW, D-SAC2022021E6, 05745000468232, D-SAI2022006HU, 05745000468669, 05745000468454, D-SAI2022011HM, D-SAC2022034EF, D-SAC2022024EC, D-Sentis-PanCancer99, 05745000468171, D-SAC2022031E9, D-SAC2022029EN, D-EU0100030050EN, D-SAI2022001HJ, D-SAC2022028EL, D-SAI2022019J5, D-SAC2022035EH, D-SAC2022001DY, 05745000468362, D-SAC2022025EE, 05745000468409, D-SAC2022005E8, D-knowliter-1KS, 05745000468348, 05745000468058, D-SAC2022036EK
Basic UDI-DI
B-MFG030065R2, 5745000468MFG010040FV, 5745000468MFG010033FY, B-SAC2022016ED, B-SAC2022018EH, 5745000468MFG010043G3, B-SAC2022003E4, 5745000468MFG010030FS, B-SIGVARNZ, B-SAI2022005HS, B-MFG030058R5, B-SAC2022017EF, B-SAI2022003HN, B-SAC2022006EA, B-SAI2022014HT, B-SAC2022015EB, B-SAC2022033ED, 5745000468EU02000500019R, B-Sentis-PanCancer-CLAD, 5745000468MFG010038GA, B-SAC2022030E7, B-SAI2022013HR, B-Sentis-LungCT-CL5D, B-MFG030063QW, B-SAC2022021E6, 5745000468MFG010037G8, B-SAI2022006HU, 5745000468EU01001100508G, B-SAI2022011HM, B-SAC2022034EF, B-SAC2022024EC, B-Sentis-PanCancer99, 5745000468MFG010019G6, B-SAC2022031E9, B-SAC2022029EN, B-EU0100030050EN, B-SAI2022001HJ, B-SAC2022028EL, B-SAI2022019J5, B-SAC2022035EH, B-SAC2022001DY, 5745000468EU0100090096BK, B-SAC2022025EE, 5745000468EU01001500019F, B-SAC2022005E8, B-knowliter-1KS, 5745000468EU0100060960BA, B-05745000468058, B-SAC2022036EK
EMDN Code
W01021399, W010699, W0102160203, W05019001, W02050182, W0101060107, W0106010399, W0102019099, W0102160704, W0103020803, W0102050213, W0201010102, Z129092, W0102039001, W0102050212, W0105010402, W0102160601, W0102019008, W0105090401, W0102030112, W0105900101, W0105900102, W05019099, W0599, W0105040519
Device Class
Class IVD General
Class A
Special Device Type
-1202
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

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Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Reagent YesEUDAMEDNoEUDAMED
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • Professional Testing
  • Surgical Instrument NoEUDAMEDYesEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • New Device: No