Manufacturer

Edan

ChinaLegal entities : Edan Instruments,Inc.

Markets : Denmark · Germany · United States

Approvals : EU – class I, IIa, IIb, A, B · United States (FDA) – 510(k) : 94 · class I, II · latest in 2026 · see on the FDA website

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

39 categories, 141 models including 141 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
Multi-parameter patient bedside monitors	Z1203020201	Central Monitoring System FTS-6 FECG1 Fetal & Maternal Monitor F122 refs Fetal & Maternal Monitor F152 refs Fetal & Maternal Monitor F63 refs 12 others Fetal Monitor F22 refs Patient Monitor CX103 refs Patient Monitor elite V53 refs Patient Monitor iM20 Patient Monitor iV100 Patient Monitor iV123 refs Patient Monitor iX103 refs Patient Monitor M503 refs Patient Monitor M83 refs Patient Monitor Neptune Patient Monitor RespArray Patient Monitor X103 refs	IIb MDR	EUDAMED record Report an error
Vital signs monitoring instruments - hardware accessories	Z12030280	Connection Cable3 refs Connection Cable SPO20902C72 refs ECG Cable3 refs ECG Cable DECG-FP3 refs ECG Cable EL03DACY1013 refs 10 others EEG Electrodes C20-M2 refs MT-300 NIBP Cuff6 refs NIBP Tube3 refs NIBP Tube BPT010101 NMT sensor Trolley (for medical use) MT-2063 refs Trolley (for medical use) MT-5033 refs Wall Mounting Bracket2 refs Water Trap 02.01.210520	I MDR	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Cleaner HC310 Cleaner HC600 Diluent HD310 Diluent HD600 Diluent HD93R 7 others Lyse HL310 Lyse HL600 Lyse HL610 Lyse HL620 Lyse HL90H Lyse HL91D Lyse HL92N	A IVDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	Electrocardiograph CS-12013 refs Electrocardiograph CS-601B3 refs Electrocardiograph iSE-12102 refs Electrocardiograph SE-123 refs Electrocardiograph SE-1200 Pro2 refs 7 others Electrocardiograph SE-12022 refs Electrocardiograph SE-153 refs Electrocardiograph SE-33 refs Electrocardiograph SE-300A3 refs Electrocardiograph SE-3012 refs PC ECG PADECG PC ECG SE-1515	IIa MDR	EUDAMED record Report an error
Internal ultrasound scanners	Z11040101	Diagnostic Ultrasound System Acclarix AX153 refs Diagnostic Ultrasound System Acclarix AX73 refs Diagnostic Ultrasound System Acclarix GX553 refs Diagnostic Ultrasound System Acclarix LX253 refs Diagnostic Ultrasound System Acclarix LX55S3 refs 4 others Diagnostic Ultrasound System U2 Diagnostic Ultrasound System U50 Diagnostic Ultrasound System U60 Digital Ultrasonic Diagnostic Imaging System DUS 60	IIa MDR	EUDAMED record Report an error
Pelvic floor rehabilitation devices - other	U070399	Biofeedback and Stimulation System P163 refs Biofeedback and Stimulation System PA353 refs Biofeedback and Stimulation System PR353 refs Biofeedback and Stimulation System Q103 refs Biofeedback and Stimulation System S103 refs 4 others Connection Cable3 refs EMG/Stimulation sensor SA13 refs EMG/Stimulation sensor SK2020WF-Y3 refs Trolley (for medical use) MT-3303 refs	I, IIa MDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Hematology Analyzer H604 refs Hematology Analyzer H6698/79 Hematology Analyzer H66S98/79 Hematology Analyzer H68S98/79 Hematology Analyzer H69S98/79 2 others Hematology Analyzer H803 refs Hematology Analyzer H903 refs	B IVDR, 98/79	EUDAMED record Report an error
Multilevel blood controls	W0103010503	Hematology Control ED-30D Hematology Control ED-30D Control N98/79 Hematology Control ED-60D Hematology Control ED-60D Control H98/79 Hematology Control ED-90D	B IVDR, 98/79	EUDAMED record Report an error
Transportable/portable multi-parameter patient monitors	Z1203020202	Telemetry Monitor iT302 refs Vital Signs Monitor ES3 Vital Signs Monitor iHM3s3 refs Vital Signs Monitor iM3 Vital Signs Monitor M33 refs	IIb MDR	EUDAMED record Report an error
ECG data management systems	Z12059009	ECG Analysis Software AI-SEMIP3 refs ECG Analysis Software Smart ECG Web Holter System AI Holter	IIa MDR	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	ECG Cable3 refs Trolley (for medical use) MT-10003 refs Trolley (for medical use) MT-2013 refs	I MDR	EUDAMED record Report an error
Foetal heartbeat detectors	Z12080103	SD1 Ultrasonic Pocket Doppler9 refs Ultrasonic TableTop Doppler2 refs	IIa MDR	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	Dye HF91D Dye HF92N Dye HF93R	A IVDR	EUDAMED record Report an error
Temperature monitoring cutaneous probes	V03010201	Temperature Probe3 refs Temperature Probe RPAYACC0373 refs Temperature Probe TP2AS22R012 refs	IIb MDR	EUDAMED record Report an error
BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)	W0201040102	Blood Gas and Chemistry Analyzer i20 Blood Gas and Chemistry Analyzer i200598/79	A IVDR, 98/79	EUDAMED record Report an error
Blood gas analysers - with classic profile (pH, PO2, PCO2, hct + electrolytes)	W0201040101	Blood Gas and Chemistry Analyzer i152 refs Blood Gas and Chemistry Analyzer i5002 refs	A IVDR	EUDAMED record Report an error
Central information computing systems	Z12030201	Central Monitoring System MFM-CMS Central Monitoring System MFM-CNS2 refs	IIb MDR	EUDAMED record Report an error
ECG holter recorders	Z12050403	Holter System SE-20033 refs Holter System SE-30122 refs	IIa MDR	EUDAMED record Report an error
Handheld ultrasound scanners	Z11040106	Diagnostic Ultrasound System Nano C53 refs Diagnostic Ultrasound System Nano OB Assist	IIa MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	SD3 VASCULAR SONOTRAX Vascular	IIa MDR	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Finger Oximeter H103 refs Pulse Oximeter H100B2 refs	IIa, IIb MDR	EUDAMED record Report an error
Various ultrasound instruments - hardware accessories	Z11049080	Multi-Transducer Connectors MTC-801 Trolley (for medical use) MT-8053 refs	I MDR	EUDAMED record Report an error
Vital signs monitoring instruments - medical device software	Z12030292	Data Management Software CMS-LITE Data Management Software Smart ECG Net	I MDR	EUDAMED record Report an error
Vital signs telemetry transmitter	Z1203020603	Telemetry Transmitter FT20 Telemetry Transmitter iT20	IIb MDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Hematology Analyzer H30 Pro3 refs	B IVDR	EUDAMED record Report an error
Blood collection, capillary tubes	W0501010203	Blood Sampler3 refs	A IVDR	EUDAMED record Report an error
Blood gas samples collection, syringes without needle	W0501010103	Blood Sampler3 refs	A IVDR	EUDAMED record Report an error
Blood pressure holter recorders	Z12050404	Ambulatory Blood Pressure Monitor3 refs	IIa MDR	EUDAMED record Report an error
Colposcopes	Z12020703	Video Colposcope C12 UHD3 refs	I MDR	EUDAMED record Report an error
Endoscope transport carts	Z12029003	Trolley (for medical use) UET	I MDR	EUDAMED record Report an error
Foetal monitors	Z12080101	Fetal Monitor FTS-6 Mobile	IIa MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	Endoscope Light Source LT302 refs	I MDR	EUDAMED record Report an error
Multi-parameter cardiovascular holter recorders (ECG, NIPB, etc.)	Z12050402	Holter ECG and ABP system3 refs	IIa MDR	EUDAMED record Report an error
Multi-parameter monitors - hardware accessories	Z1203020280	SpO2 sensor3 refs	IIb MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	Endoscope Camera System FE303 refs	I MDR	EUDAMED record Report an error
Two-dimensional linear-array transcutaneous ultrasound probes	Z110402010101	ultrasonic transducer C352UB3 refs	IIa MDR	EUDAMED record Report an error
Ultrasound probes - other	Z11040299	Ultrasonic Transducer BT6-US3 refs	IIa MDR	EUDAMED record Report an error
Vital signs telemetry instruments - hardware accessories	Z1203020680	Fetal Telemetry System FTS-3	IIb MDR	EUDAMED record Report an error
Whole blood calibrators	W0103010507	Hematology Calibrator ED-CAL PLUS	B IVDR	EUDAMED record Report an error

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