Manufacturer

Daan Gene

ChinaLegal entities : Daan Gene Co., Ltd.

First countries of placing on the market declared in EUDAMED : Denmark, France, Germany, Netherlands, Slovakia, Spain, Sweden

EU representative : Lotus NL B.V. (Netherlands)

21 categories, 70 models including 70 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
IVD general use consumable devices - other	W0599	Nucleic Acid Extraction Kit DA06003 refs Nucleic Acid Extraction Kit DA10003 refs Nucleic Acid Isolation or Purification Kit3 refs Nucleic Acid Isolation or Purification Reagent3 refs RNA/DNA Extraction or Purification Kit DA06403 refs 8 others RNA/DNA Extraction or Purification Kit DA06502 refs RNA/DNA Extraction or Purification Kit DA06603 refs RNA/DNA Extraction or Purification Kit DA12703 refs RNA/DNA Purification Kit (Magnetic Bead) DA06303 refs RNA/DNA Purification Kit (Preservation) DA09403 refs RNA/DNA Purification Kit (Preservation/Release) DA0960 RNA/DNA Purification Kit (Release) DA09503 refs RNA/DNA Purification Kit (Spin Column)2 refs	A IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	1 tests/kit2 refs98/79 25 tests/kit2 refs98/79 Large package, 24 tests/kit5 refs98/79 Large package, 48 tests/kit8 refs98/79 Large package, 480 tests/kit3 refs98/79 5 others Large package, 96 tests/kit6 refs98/79 Large package, 960 tests/kit3 refs98/79 Single tube, 24 tests/kit2 refs98/79 Single tube, 48 tests/kit2 refs98/79 Single tube, 96 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automatic Nucleic Acid Extraction Instrument Swift96，Stream SP96，Ballet X33 refs NAE16 Nucleic Acid Extraction Instrument Smart32 ，Smart32plus Rapid Detection System T-elfie Real-time PCR Detection System Lava96	A IVDR	EUDAMED record Report an error
Enterovirus - NA reagents	W0105040502	24 tests/kit2 refs98/79 Large package, 10 tests/kit2 refs98/79 Large package, 48 tests/kit2 refs98/79 Single tube, 10 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	24 tests/kit5 refs98/79 Large package, 24 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	20 tests/kit3 refs98/79 Large package, 20 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 20 tests/kit98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis detection by NA reagents	W0105010117	Large package, 20 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 20 tests/kit98/79	– 98/79	EUDAMED record Report an error
Dengue virus - NA reagents	W0105040511	Large package, 10 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 10 tests/kit98/79	– 98/79	EUDAMED record Report an error
Ebv - NA reagents	W0105040403	Large package, 20 tests/kit2 refs98/79 Large package, 48 tests/kit98/79 Single tube, 20 tests/kit3 refs98/79	– 98/79	EUDAMED record Report an error
Gonococcal detection by NA reagents	W0105010203	Large package, 20 tests/kit2 refs98/79 Large package, 48 tests/kit98/79 Single tube, 20 tests/kit4 refs98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Large package, 10 tests/kit98/79 Large package, 48 tests/kit98/79 Single tube, 10 tests/kit98/79	– 98/79	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	48 tests/kit2 refs98/79 Large package, 24 tests/kit98/79 Large package, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Single tube, 10 tests/kit2 refs98/79 Single tube, 20 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
Samples transport, containers - other	W05020199	Specimen Preservation Reagent3 refs Specimen Preservation Solution3 refs	A IVDR	EUDAMED record Report an error
Zika virus - NA reagents	W0105040531	Large Package, 24 tests/kit98/79 Large Package, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Avian influenza - NA reagents	W0105040515	48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents	W0105040514	Large package, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis b virus - NA reagents	W0105020216	Large package, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hepatitis c virus - NA reagents	W0105020307	Large package, 48 tests/kit98/79	– 98/79	EUDAMED record Report an error
Histological samples analysers	W02020501	Auto FICA-300	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Sample Processing System Stream DP96	A IVDR	EUDAMED record Report an error

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