Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013783488

FEI Number

3013783488

Entity Name

ORANTECH INC.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,, Shenzhen Guangdong 518106, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Orantech Inc. (Owner Number: 10058634)

Owner / Operator Contact Address

Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District,, Shenzhen, CN-GD 518106, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K823670

PMA Number

N/A

All Registered Proprietary Names

Accessories-Purpose Spo2 sensors securement device; Orantech Y sensor, Nellcor D-YS sensor and Masimo Multi-site sensor Water trap; Water trap set Oral-pharyngeal Airway Flexi 2G SAD Introducer; Guedel Airway; Laryngeal Mask; Laryngeal Mask introducer; Laryngeal Mask W/Gastirc Access; Leg plate adaptors ECG Trunk cables and leadwires, Trunk Cables(IBP cables, Spo2 cables, Temp. Cables), Adapter cables, Adaptors, Bandage, Elastic manometer, cuff, cuff bladder, inflation bulb and optioned Blood pressure cuffs (Adult/Pediatric/Infant/Neonate) Tenacore fetal ultrasound and toco transducers Breathing circuit adaptor BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m Carbon Dioxide monitoring CTM EtCo2 sensor Aneroid Sphygmomanometer Reusable Spo2 sensors and Disposable Spo2 sensors IT Dr.Gamber medical oxygen sensors OS and M series TS series skin and general/oral temperature probes Accessories of Tourniquet, Pneumatic -Reusable tourniquet Cuffs, Disposable tourniquet Cuffs, air hoses, connectors Non Invasive Blood Pressure Measurement Hose; Reusable NIBP Hose; Connection tube Electrosurgical Pads ECG/EKG trunk cables and lead wires, Disposable ECG lead wires Pressure Hose Assemblies Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-03-03
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2023-07-28
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2025-12-10
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2018-10-28
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-12-05
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-04-23
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-04-23
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2018-10-17
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2021-10-28
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2023-12-07
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-10-17
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2024-05-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-17
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2022-04-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-10-17
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2025-05-12
KCY	Tourniquet, Pneumatic	General, Plastic Surgery	Class 1	878.5910	2022-04-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-04-23
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2022-04-23
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	Class 2	884.2720	2022-04-23
HFN	Transducer, Pressure, Intrauterine	Obstetrics/Gynecology	Class 2	884.2700	2022-04-23
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2022-04-23
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2022-04-23
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2022-04-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2022-04-23
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2022-04-23
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2022-04-23
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2022-04-23
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2022-04-23
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2022-04-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2022-04-23
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2022-04-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2022-04-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2022-04-23
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2022-04-23
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2022-04-23
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-04-23
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	Class 1	890.1600	2022-03-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-06-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2019-06-27
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2024-08-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-07-24

Official Correspondent

Yuanlan Zeng

US Agent Details

Andres Orjuela Business: Medten USA Inc. Email: andres@medten.com Phone: (925) 3599115

Related Public Records

Same Entity

Orantech Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K831001	Frontier Products	UNICUFF-BLOOD PRESSURE CUFF	1983-07-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2
Z-0034-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube, oxygen supply tubing, sideport connector with adjustable bleed valve, ported elbow and infant mask; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83100-24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013783488. Last updated year: 2026. Please use registration number 3013783488 when referencing this establishment in official correspondence.