Manufacturer

Gongdong

ChinaLegal entities : Zhejiang Gongdong Medical Technology Co., Ltd.,

Markets : France · Germany · Poland · Romania · Türkiye · United States

Approvals : EU – class I, IIa, A · United States (FDA) – 510(k) : 3 · class I, II · latest in 2025 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

8 categories, 67 models including 67 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
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Category	EMDN code	Registered models	Class	Contact
Blood collection, capillary tubes	W0501010203	3.2%Sodium citrate without capillary tube EDTA.K2 capillary tube EDTA.K3 capillary tube GDC005A（No addition with capillary tube） Heparin lithium capillary tube GD-LH 23 others Heparin sodium + Sodium Fluoride capillary tube GD-SFH Heparin sodium capillary tube GD-SH Micro Blood Collection Tube 3.2%Sodium citrate with capillary tube2 refs Micro Blood Collection Tube 3.8%Sodium citrate with capillary tube Micro Blood Collection Tube Clot activator with capillary tube GDC005CA2 refs Micro Blood Collection Tube Heparin Lithium+Gel with capillary tube GDC005LHG Micro Blood Collection Tube Sodium Flouride+Potassium Oxalate with capillary tube2 refs Micro Blood Collection Tube(Clot activator without capillary tube) GD005CA Micro Blood Collection Tube(EDTAK2 with capillary tube) Micro Blood Collection Tube(EDTAK2 without capillary tube) Micro Blood Collection Tube(EDTAK3 with capillary tube) Micro Blood Collection Tube(EDTAK3 without capillary tube) Micro Blood Collection Tube(Gel+Clot activator with capillary tube) GDC005SGC Micro Blood Collection Tube(Gel+Clot activator without capillary tube) GD005SGC Micro Blood Collection Tube(Heparin lithium with capillary tube) GDC005LH Micro Blood Collection Tube(Heparin lithium without capillary tube) GD005LH Micro Blood Collection Tube(Heparin sodium + Sodium Fluoride with capillary tube) GDC005SFH Micro Blood Collection Tube(Heparin sodium + Sodium Fluoride without capillary tube) GD005SFH Micro Blood Collection Tube(Heparin sodium with capillary tube) GDC005SH Micro Blood Collection Tube(Heparin sodium without capillary tube) GD005SH Micro Blood Collection Tube(No addition without capillary tube) No addition capillary tube Sodium Flouride+Potassium Oxalate capillary tube	A IVDR	EUDAMED record Report an error
Blood collection, tubes with additives or serum separator	W050101010201	Disposable Vacuum Blood Tube19 refs Disposable Vacuum Blood Tube 3.2%Sodium citrate3 refs Disposable Vacuum Blood Tube cf-DNA3 refs Disposable Vacuum Blood Tube EDTA K2+ Gel Disposable Vacuum Blood Tube EDTA K3+Sodium Fluride3 refs 12 others Disposable Vacuum Blood Tube Heparin sodium+Sodium fluoride3 refs Disposable Vacuum Blood Tube Thrombin3 refs Disposable Vacuum Blood Tube Thrombin+Gel Disposable Vacuum Blood Tube(Clot activator)3 refs Disposable Vacuum Blood Tube(clot activator+Gel)3 refs Disposable Vacuum Blood Tube(EDTA.K2)3 refs Disposable Vacuum Blood Tube(EDTA.K3)3 refs Disposable Vacuum Blood Tube(EDTA.Na2)3 refs Disposable Vacuum Blood Tube(EDTA.Na2+Sodium fluoride)3 refs Disposable Vacuum Blood Tube(3.8% sodium citrate)3 refs EDTA K3+ Gel EDTA Na2+ Gel	A IVDR	EUDAMED record Report an error
Samples collection devices - other	W05019099	boric acid + sodium formate + sodium borate3 refs Centrifuge tube D1001G Cryovial tube3 refs Plastic Test Tubes G10012 refs Plastic Test Tubes G1001G2 refs 7 others Plastic Transfer Pipette F1016-1 Specimen container3 refs Specimen container boric acid + sodium formate + sodium borate3 refs Specimen container faeces container, secretion container, human urine container, human secretion for culture container.3 refs Specimen container No addition6 refs Transfer Pipette F1016-1 G Urine Transfer Straw yellow pp	A IVDR	EUDAMED record Report an error
Urine collection, tubes	W05010202	Disposable Urine Collection Tube boric acid3 refs Disposable Urine Collection Tube boric acid + sodium formate + sodium borate2 refs Disposable Urine Collection Tube No addition2 refs Disposable Urine Collection Tube sodium fluoride/sodium borate2 refs Disposable Urine Collection Tube Sodium Propionate +Ethyl Paraben+ Chlorhexidine2 refs 1 other Gongdong Yellow	A IVDR	EUDAMED record Report an error
Apheresis platelet collection devices	B030102	PRF Tubes A Type、S type、I type3 refs	IIa MDR	EUDAMED record Report an error
Faeces collection devices	W05019001	Specimen container faeces container, secretion container, human urine container, human secretion for culture container.3 refs	A IVDR	EUDAMED record Report an error
Scialytic lamp lighting systems - other	Z12010799	Light handle cover A-type、B-type、C-type3 refs	I MDR	EUDAMED record Report an error
Urine collection, containers	W05010203	Curalyn Urine Container	A IVDR	EUDAMED record Report an error

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