Manufacturer

Nanjing Norman Biological Technology

ChinaLegal entities : Nanjing Norman Biological Technology Co., Ltd.

Markets : Belgium · Bulgaria · Germany · Italy

Approvals : EU – class A

EU representative : Sungo Cert GmbH (Germany)

13 categories, 37 models including 37 on the market, 1 country

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
Other interleukins (except for il-6)	W01030606	Interleukin-10(IL-10) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-10(IL-10) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-10(IL-10) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 50tests/box98/79 4 others Interleukin-1β(IL-1β) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-8(IL-8) Test Kit (Chemiluminescence) 50×2tests/box98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Test Kit (Chemiluminescence) 100tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50tests/box98/79 D-Dimer Test Kit (Chemiluminescence) 50×2tests/box98/79 D-Dimer Test Kit (Immunofluorescence) 25 Tests /Box98/79 D-Dimer Test Kit (Immunoturbidimetry) 50tests/box98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin 6 (IL-6) Test Kit (Chemiluminescence) 50×2tests/box98/79 Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 25 Tests /Box98/79	– 98/79	EUDAMED record Report an error
Coagulation factors - other	W0103020299	Des-gamma-carboxy prothrombin (DCP) Test Kit (Chemiluminescence) 100tests/box98/79 Des-gamma-carboxy prothrombin (DCP) Test Kit (Chemiluminescence) 50tests/box98/79 Des-gamma-carboxy prothrombin (DCP) Test Kit (Chemiluminescence) 50×2tests/box98/79	– 98/79	EUDAMED record Report an error
Interleukins receptors (il-2r,il6r ...)	W01030607	Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 100tests/box98/79 Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 50tests/box98/79 Interleukin-2 Receptor(IL-2R) Test Kit (Chemiluminescence) 50×2tests/box98/79	– 98/79	EUDAMED record Report an error
Tumour necrosis factors (tnfα,tnfβ, ...)	W01030603	Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 100tests/box98/79 Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 50tests/box98/79 Tumor Necrosis Factor (TNF) Test Kit (Chemiluminescence) 50×2tests/box98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	FI-1200 NRM-FI-1000	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	NORMAN-CL211,NRM411-S7 NORMAN-CL211A	A IVDR	EUDAMED record Report an error
IVD general use consumables devices - other accessories	W0580	Specification 1(Substrate 1:100ml,Substrate 2:100ml), Specification 2(Substrate 1:200ml,Substrate 2:200ml), Specification 3(Substrate 1:500ml,Substrate 2:500ml), Specification 4(Substrate 1:1L,Substrate 2:1L)3 refs Wash buffer 100ml,200ml,500ml,1L,2L,5L3 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	NRM411	A IVDR	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrin (proto) Degradation Product (FDP) Test Kit (Immunofluorescence) 25 Tests /Box98/79	– 98/79	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	Cuvette 504pcs/bag	A IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	240μL/tube,300μL/tube,400μL/tube,500μL/tube,600μL/tube,800μL/tube,1mL/tube,1.5mL/tube,2.0mL/tube,2.5mL/tube,3.0mL/tube,3.5mL/tube,5mL/tube,6mL/tube3 refs	A IVDR	EUDAMED record Report an error

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