Manufacturer

Contecmed

ChinaLegal entities : Contec Medical Systems Co., Ltd.

Markets : Belgium · Croatia · Denmark · France · Germany · Greece · Hungary · Italy · Netherlands · Poland · Romania · Spain · United States

Approvals : EU – class I, IIa, IIb, A, C · United States (FDA) – 510(k) : 12 · class I, II · latest in 2024 · see on the FDA website

EU representative : Prolinx GmbH (Germany)

Website pms.qms@contecmed.com

24 categories, 89 models including 89 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
Pulse oximeters	Z1203020408	Pulse Oximeter ANP10093/42 Pulse Oximeter CMS50-Pro93/42 Pulse Oximeter CMS50D+93/42 Pulse Oximeter CMS50D-BT93/42 Pulse Oximeter CMS50D193/42 30 others Pulse Oximeter CMS50D293/42 Pulse Oximeter CMS50D2-193/42 Pulse Oximeter CMS50DL, CMS50D2 refs Pulse Oximeter CMS50DL193/42 Pulse Oximeter CMS50DL293/42 Pulse Oximeter CMS50E93/42 Pulse Oximeter CMS50F93/42 Pulse Oximeter CMS50I93/42 Pulse Oximeter CMS50M93/42 Pulse Oximeter CMS50N93/42 Pulse Oximeter CMS50Q193/42 Pulse Oximeter CMS50QA93/42 Pulse Oximeter CMS50QB93/42 Pulse Oximeter CMS60C93/42 Pulse Oximeter CMS60D93/42 Pulse Oximeter CMS60D193/42 Pulse Oximeter CMS70A93/42 Pulse Oximeter NX-8740-67593/42 Pulse Oximeter PO-10093/42 Pulse Oximeter PO-20093/42 Pulse Oximeter PO-200A Solo93/42 Pulse Oximeter PO-200Solo93/42 Pulse Oximeter PO-23093/42 Pulse Oximeter PO-25093/42 Pulse Oximeter PO-30093/42 Pulse Oximeter PO-40093/42 Pulse Oximeter PO-650A93/42 Pulse Oximeter PO-650B93/42 Pulse Oximeter PO-90093/42 Pulse Oximeter SAT-50093/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Non-invasive blood pressure monitoring instruments	Z1203020302	Ambulatory Blood Pressure Monitor ABDM-5093/42 Ambulatory Blood Pressure Monitor ABPM50 Electronic Sphygmomanometer BP-10093/42 Electronic Sphygmomanometer CONTEC07A Electronic Sphygmomanometer CONTEC08A 4 others Electronic Sphygmomanometer CONTEC08A-BT93/42 Electronic Sphygmomanometer CONTEC08C Electronic Sphygmomanometer CONTEC08D93/42 Electronic Sphygmomanometer CONTEC08E93/42	IIa MDR, 93/42	EUDAMED record Report an error
Foetal heartbeat detectors	Z12080103	Pocket Fetal Doppler Baby Sound A93/42 Pocket Fetal Doppler Baby Sound B93/42 Pocket Fetal Doppler Baby Sound C93/42 Pocket Fetal Doppler Baby Sound C193/42 Pocket Fetal Doppler CONTEC10A93/42 3 others Pocket Fetal Doppler CONTEC10B93/42 Pocket Fetal Doppler CONTEC10C, CONTEC10CL2 refs Pocket Fetal Doppler Sonoline C93/42	IIa MDR, 93/42	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	ECG Workstation CONTEC8000G Electrocardiograph ECG100G93/42 Electrocardiograph ECG1212G, ECG90A, ECG300G, ECG600G, ECG1200G, E3, E3M, E6, E12, E18M3 refs Electrocardiograph ECG300GT93/42 Portable ECG Monitor PM10	IIa MDR, 93/42	EUDAMED record Report an error
Ultrasonic nebulisers	Z12040210	Mesh Nebulizer IN-10093/42 Mesh Nebulizer NE-M01, NE-M01L2 refs Mesh Nebulizer NE-M0393/42 Mesh Nebulizer NE-M03A93/42 Mesh Nebulizer NE-M03B93/42	IIa MDR, 93/42	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	Patient Monitor CMS600093/42 Patient Monitor CMS700093/42 Patient Monitor CMS800093/42 Patient Monitor CMS900093/42	IIb 93/42	EUDAMED record Report an error
Clinical/diagnostic spirometers	Z12150101	Spirometer SP1093/42 SPIROMETER SP80B	IIa MDR, 93/42	EUDAMED record Report an error
Electroencephalographs	Z12100302	Digital Brain Electric Activity Mapping KT88 Digital Brain Electric Activity Mapping KT88-240093/42	IIa MDR, 93/42	EUDAMED record Report an error
Non-contact digital thermometers	V0301010202	Infrared Thermometer TP500 Infrared Thermometer TP60093/42	IIa MDR, 93/42	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Urine Analyzer BC400 Urine analyzer BC401	A IVDR	EUDAMED record Report an error
Vital signs monitoring instruments - other	Z12030299	Sleep apnea screen meter RS01 Sleep apnea screen meter SAS-50093/42	IIa MDR, 93/42	EUDAMED record Report an error
Blood glucose meters	W0201060102	Blood Glucose Meter BGM10A，BGM10A-BV，BGM10A-L，BGM10B，BGM10B-BV，BGM10B-L，BGM10C，BGM10C-BV，BGM10C-L，BGM10D，BGM10D-BV，BGM10D-L，BGM10E，BGM10E-BV，BGM10E-L，BGM10F，BGM10F-BV，BGM10F-L，BGM10G，BGM10G-BV，BGM10G-L3 refs	C IVDR	EUDAMED record Report an error
Carbon dioxide analysers	Z1203020401	Capnograph CA10M	IIa MDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Semi-auto Biochemistry Analyzer BC300	A IVDR	EUDAMED record Report an error
ECG holter recorders	Z12050403	Dynamic ECG Systems TLC5000, TLC60002 refs	IIa MDR	EUDAMED record Report an error
Electromyographs	Z12100401	EMG/EP System CMS6600B, CMS66002 refs	IIa MDR	EUDAMED record Report an error
Foetal monitors	Z12080101	Fetal Monitor CMS800G	IIa MDR	EUDAMED record Report an error
General medicine diagnosis and monitoring instruments - hardware accessories	Z12040180	NIBP Cuff I Series3 refs	I MDR	EUDAMED record Report an error
Infusion pumps	Z12030301	Infusion Pump SP750	IIb MDR	EUDAMED record Report an error
Obstetric/gynaecological ultrasound scanners	Z11040105	Color Doppler Ultrasound Diagnostic System CMS1700B, CMS1700C2 refs	IIa MDR	EUDAMED record Report an error
Oxygen concentrators	Z12159004	Oxygen Concentrator CONTEC21	IIb MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	B-Ultrasound Diagnostic System CMS600P2	IIa MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - other	Z129099	Insect bite helper KT100, KT101, KT102, KT103, KT104, KT1203 refs	IIa MDR	EUDAMED record Report an error
Video laryngoscopes	Z12021004	Video Laryngoscope CMS-GS1	I MDR	EUDAMED record Report an error

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