IVD generic use consumablesSamples collection devicesSamples collection devices - various

Saliva collection devices

EMDN code W05019002

46 manufacturers, 68 models including 66 on the market, 15 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 46

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

Manufacturer	Country	Registered models	Class	Contact
Suzhou Shengtian Biotechnology EU representative : Kingsmead Service B.V. (Netherlands)	China	Oral Fluid Collection Kit STGJ01 Oral Fluid Collection Kit STGJ02 Oral Fluid Collection Kit STGJ03 Oral Fluid Collection Kit STGJ04 Oral Fluid Collection Tube STGJ0101 3 others Oral Fluid Collection Tube STGJ0201 Oral Fluid Collection Tube STGJ0301 Oral Fluid Collection Tube STGJ0401	A IVDR	EUDAMED record Report an error
Norgen Biotek EU representative : Emergo Europe B.V. (Netherlands)	Canada	EZCollect Saliva DNA Device Dx EZCollect Saliva RNA Device Dx Saliva DNA Collection and Preservation Devices Dx Saliva RNA Collection and Preservation Devices Dx	A IVDR	Website regulatory@norgenbiotek.com EUDAMED record Report an error
Suntrine EU representative : Kingsmead Service B.V. (Netherlands)	China	Preservation tube 513001 Saliva Sample Collector 904001 Saliva Sample Collector 904201 Viral Tranport Meidum Tube With Swab 903101	A IVDR	service@suntrine.com EUDAMED record Report an error
Linear FDA	Spain	Saliva collectors. Paper-poly pouch package Saliva collectors. With medium. Blister package Saliva collectors. With medium. Paper-poly pouch package2 refs	A IVDR	Website info@linear.es EUDAMED record Report an error
ALS Life Sciences Portugal	Portugal	SalivaGene® Collector SalivaGene® Swab Comfort	A IVDR	Website EUDAMED record Report an error
DNA Genotek FDA EU representative : QbD RepS BV (Belgium)	Canada	OMNIgene ORAL2 refs ORAgene DNA3 refs	A IVDR	Website regulatory@dnagenotek.com EUDAMED record Report an error
Hanhengmed FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B83 refs HH-5、HH-10、HH-5-A2、HH-5-A3、HH-10-A2、HH-10-A3、HH-10-A4、HH-10-A5、HH-10-A6、HH-10-A83 refs	A IVDR	quality@hanhengmed.com EUDAMED record Report an error
Hubei V-Medical Products FDA EU representative : RAFFIN MEDICAL (France)	China	Cups 60ml，90ml，100ml，120ml，150ml，200ml，250ml，500ml，1000ml3 refs Dental sponge ES50STERILE	I MDR	Website quality-liutao@v-medicalchina.com EUDAMED record Report an error
Kangjian FDA EU representative : Zoustech S.L. (Spain)	China	saliva collection and preservation system98/79 Type B	A IVDR, 98/79	EUDAMED record Report an error
Weihai Sunway Medical Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Saliva specimen container Saliva specimen tube	A IVDR	EUDAMED record Report an error
Zymo Research FDA EU representative : DAVID Catherine Elisabeth Marie (France)	United States	DNA/RNA Sample Collection Kit R2000-A DNA/RNA Shield SafeCollect Saliva Collection Kit R1160-E3 refs	A IVDR	info@zymoresearch.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Saliva Collection System CS-S01	A IVDR	Website contact@diareagent.com EUDAMED record Report an error
Beaverbio EU representative : Kingsmead Service B.V. (Netherlands)	China	Saliva Collector 43806	A IVDR	sales@beaverbio.com EUDAMED record Report an error
Cell Projects FDA EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	12 X GFX Saliva collector (includes funnel, tube filled with 2ml stabilization buffer, cap & instruction manual)3 refs	A IVDR	Website EUDAMED record Report an error
Cerascreen	Germany	Cortisol Test3 refs	A IVDR	Website EUDAMED record Report an error
Chengwumedical EU representative : SUNGO Europe B.V. (Netherlands)	China	Saliva Kit 001;Saliva Kit 002;Saliva Kit Without VTM 001;Saliva Kit Without VTM 002;Full Saliva Kit;Saliva Kit without VTM.3 refs	A IVDR	EUDAMED record Report an error
Citotest FDA EU representative : Obelis s.a. (Belgium)	China	CITOSWAB2 refs	A IVDR	Website info@citotest.com EUDAMED record Report an error
Dnameter	Czechia	DNAmeter	A IVDR	EUDAMED record Report an error
FertiPro FDA	Belgium	Blue Collect IB_CD01	A IVDR	Website info@fertipro.com EUDAMED record Report an error
for you eHealth	Germany	for you hormon-status frau3 refs	I MDR	Website info@foryouehealth.de EUDAMED record Report an error
Haimen Shengbang Laboratory Equipment FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	90ml	A IVDR	EUDAMED record Report an error
Happy Innova	Spain	The Smart Lollipop One	A IVDR	Website hello@thesmartlollipop.com EUDAMED record Report an error
IBL International	Germany	SaliCap Set2 refs	A IVDR	Website EUDAMED record Report an error
Ilabu	Poland	ILabU zestaw do samodzielnego pobierania próbki: ślina	I MDR	Website EUDAMED record Report an error
Jiangsu Comeon Medical Apparatus EU representative : Sungo Cert GmbH (Germany)	China	Saliva collector	A IVDR	EUDAMED record Report an error
Jiangsu CoWin Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	CWX021S/CWX021M/CWX024M3 refs	A IVDR	EUDAMED record Report an error
Jiangsu Mole Bioscience EU representative : Lotus NL B.V. (Netherlands)	China	Saliva Collection Kit PS01005F04C20103 refs	A IVDR	EUDAMED record Report an error
Mavie	Austria	MavieMe Saliva Collection Kit MMSAL5	A IVDR	Website EUDAMED record Report an error
Medichecks EU representative : CS Life Sciences Europe Ltd (Ireland)	United Kingdom (ex Northern Ireland)	Saliva Sample Collection Kit KSL-COR-ACT2 refs	A IVDR	Website qualityandregs@medichecks.com EUDAMED record Report an error
Medico Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	SALIVA COLLECTION KIT MHM-A,MHM-B2 refs	A IVDR	info@medicoswab.com EUDAMED record Report an error
Microgenics FDA EU representative : B·R·A·H·M·S GmbH (Germany)	United States	OraTrust Oral Fluid Collection System B400017642 refs	A IVDR	Website EUDAMED record Report an error
Microtrace	Italy	Sistema di raccolta campioni di saliva per invio e analisi di laboratorio - PROFILI ORMONALI3 refs	A IVDR	Website office@microtrace.it EUDAMED record Report an error
Miraclean Technology FDA EU representative : Share info GmbH (Germany)	China	Saliva Collection Kit TY180, TY180F, TY180D, TY001A, TY001AF, TY001D, TY001B, TY002A-10.0, TY002AF-10.0, TY002AD-10.0, TY002B-10.0, TY003A-5.0, TY003AF-5.0, TY003AD-5.0,TY003B-5.0, TY004A-6.0, TY004AF-6.0, TY004AD-6.0,TY004B-6.03 refs	A IVDR	EUDAMED record Report an error
Novogenia FDA	Austria	Novo Saliva Kit VSKP	A IVDR	Website service@novogenia.com EUDAMED record Report an error
Oacp	Ireland	SSAL-601-0	A IVDR	Website EUDAMED record Report an error
Randox FDA	Northern Ireland	Home Saliva Collection Kit SCK10654	A IVDR	Website EUDAMED record Report an error
Remi Health	Germany	Collection Kit 13	I MDR	Website EUDAMED record Report an error
Sarstedt FDA	Germany	Salivette®3 refs	A IVDR	Website EUDAMED record Report an error
Shandong Chengwu Ronghua Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Single-use sampling device2 refs	I MDR	EUDAMED record Report an error
Taizhou Huangyan Fangye Technology Development EU representative : Sungo Cert GmbH (Germany)	China	10ml	A IVDR	EUDAMED record Report an error
TimeTeller	Germany	TimeTeller® – Your Circadian Rhythm	A IVDR	EUDAMED record Report an error
Wuhan MGI Tech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Saliva Sample Collection Kit SSC022 refs	A IVDR	EUDAMED record Report an error
Xiamen Zeesan Biotech FDA EU representative : Lotus NL B.V. (Netherlands)	China	Saliva DNA Sample Collection Kit2 refs	A IVDR	info@zsandx.com EUDAMED record Report an error
Zhucheng Binfei Medi-Tek EU representative : CMC Medical Devices & Drugs SL (Spain)	China	BINFEI3 refs	I MDR	admin@binfei-medtek.com EUDAMED record Report an error
Lykon No model still on the market	Germany	Cortisol Test (v3) SW-RO2 refs (no longer marketed)	I MDR	quality@lykon.com EUDAMED record Report an error
MolGen No model still on the market	Netherlands	MolGen Saliva Collector 08720299830509 (no longer marketed)	A IVDR	Website info@molgen.com EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Other manufacturers known in the United States (FDA) 10

Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.

Manufacturer	Country	Brands	FDA clearance
Color Diagnostics, LLC	United States	Color Saliva Collection Kit	registered
23andMe Genomics LLC	United States	–	registered
ALOM TECHNOLOGIES CORPORATION	United States	–	registered
Amphenol Critical Medical Technologies, LLC	United States	–	registered
Ancestry Genomics, Inc.	United States	–	K192947 (2020)
L-D Tool & Die Division of Madix Engineering	Canada	–	registered
Labcorp Genetics	United States	–	registered
OraSure Technologies, Inc. Present in Europe in other categories	United States	–	registered
Progenika Biopharma S.A. Present in Europe in other categories	Spain	–	registered
Southmedic, Inc.	Canada	–	registered

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