Contec Medical Systems Co., Ltd.

Address:No.112 Qinhuang West Street,Qinhuangdao Hebei,CN

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (2) Oximeter, Infrared, Sporting, Aviation (OCH) (2) Oximeter, Wellness (PGJ) (2) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Automated Urinalysis System (KQO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1) Electrocardiograph (DPS) (1) Scale, Stand-On, Patient (FRI) (1)

Premarket Exempt

No Yes

Clear

CONTEC - 06945040101161 Catalog Number :

Device Description : B-Ultrasound Diagnostic System

Device Class : 2

Duns Number: 529606295

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

CONTEC - 06945040101369 Catalog Number :

Device Description : urine analyzer

Device Class : 1

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : KQO

Prescription Use : No

Device Count : 1

CONTEC - 06945040101376 Catalog Number :

Device Description : Electronic Bathroom Scale

Device Class : 1

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : FRI

Prescription Use : No

Device Count : 1

CONTEC - 06945040101406 Catalog Number :

Device Description : Dynamic ECG Systems

Device Class : 2

Duns Number: 529606295

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

CONTEC - 06945040101437 Catalog Number :

Device Description : Pulse Oximeter

Device Class : 2

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : PGJ

Prescription Use : No

Device Count : 1

CONTEC - 06945040101468 Catalog Number :

Device Description : Wearable SpO2/ECG Monitor

Device Class : 2

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : PGJ

Prescription Use : No

Device Count : 1

CONTEC - 06945040101499 Catalog Number :

Device Description : Dynamic ECG Systems

Device Class : 2

Duns Number: 529606295

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

CONTEC - 06945040101505 Catalog Number :

Device Description : Portable ECG Monitor

Device Class : 2

Duns Number: 529606295

Premarket Exempt : No

Product Code : DPS

Prescription Use : No

Device Count : 1

CONTEC - 06945040101567 Catalog Number :

Device Description : Pulse Oximeter

Device Class : 2

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

CONTEC - 06945040101574 Catalog Number :

Device Description : Pulse Oximeter

Device Class : 2

Duns Number: 529606295

Premarket Exempt : Yes

Product Code : OCH

Prescription Use : No

Device Count : 1

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