Orantech Inc.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 40 device types, 20 products catalogued, 5 clearances.
Orantech Inc. is a contract manufacturer holding a current FDA establishment registration. The registration covers Oximeter, Bandage, Elastic and 38 other device types. 20 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
40device types registered with the FDA
20products catalogued under its own name
5510(k) clearances
Registration
| Registered name | ORANTECH INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013783488 |
| FEI number | 3013783488 |
| DUNS | 544423370 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市橙汇科技有限公司 |
|---|---|
| Unified social credit code | 91440300349737507E |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Zone#A,4F,1st Bld,7th Industrial Zone,Yulv Community, GongMing, Guangming New District, |
| Postal code | 518106 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Airway, Oropharyngeal, Anesthesiology | Class 1 | Oral-pharyngeal Airway, Flexi 2G SAD Introducer; Guedel Airway; Laryngeal Mask; Laryngeal Mask introducer; Laryngeal Mask W/Gastirc Access; | 2025 | 84 |
| Alarm, Blood-Pressure | Class 2 | 2022 | 7 | |
| Amplifier And Signal Conditioner, Transducer Signal | Class 2 | 2022 | 4 | |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | Carbon Dioxide monitoring CTM EtCo2 sensor | 2018 | 29 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | Class 2 | IT Dr.Gamber medical oxygen sensors OS and M series | 2022 | 8 |
| Bandage, Elastic | Class 1 | Bandage, Elastic | 2023 | 280 |
| Blood Pressure Cuff | Class 2 | Aneroid Sphygmomanometer, Blood pressure cuffs (Adult/Pediatric/Infant/Neonate), manometer, cuff, cuff bladder, inflation bulb and optioned | 2018 | 50 |
| Cable, Electrode | Class 2 | Leg plate adaptors, ECG Trunk cables and leadwires, Trunk Cables(IBP cables, Spo2 cables, Temp. Cables), Adapter cables, Adaptors, | 2018 | 47 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | ECG/EKG trunk cables and lead wires, Disposable ECG lead wires | 2019 | 22 |
| Cannula, Nasal, Oxygen | Class 1 | 2025 | 97 | |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | Breathing circuit adaptor, BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m | 2023 | 55 |
| Clinical Electronic Thermometer | Class 2 | Probe Covers; Disposable Ear Thermometer Probe Cover | 2026 | 49 |
| Computer, Blood-Pressure | Class 2 | 2022 | 12 | |
| Computer, Diagnostic, Pre-Programmed, Single-Function | Class 2 | 2022 | 5 | |
| Continuous Measurement Thermometer | Class 2 | TS series skin and general/oral temperature probes | 2018 | 115 |
| Detector And Alarm, Arrhythmia | Class 2 | 2022 | 10 | |
| Device, Medical Examination, Ac Powered | Class 1 | Examination Lights | 2024 | 18 |
| Drain, Tee (Water Trap) | Class 1 | Water trap; Water trap set | 2023 | 12 |
| Electrode, Electrocardiograph | Class 2 | Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes | 2022 | 33 |
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Electrosurgical Pads, Disposable Electrosurgical Active Electrodes (Electrosurgical Pencils) | 2025 | 65 |
| Infusor, Pressure, For I.V. Bags | Class 1 | Pressure infusion bag, reusable and disposable 500ml/1000ml/3000ml | 2021 | 25 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Class 2 | 2022 | 9 | |
| Monitor, Uterine Contraction, External (For Use In Clinic) | Class 2 | 2022 | 2 | |
| Orthosis, Limb Brace | Class 1 | Calf thigh DVT; dvt sleeve | 2025 | 144 |
| Oximeter | Class 2 | Reusable Spo2 sensors and Disposable Spo2 sensors, Fingertip Pulse Oximeter | 2018 | 70 |
| Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Class 2 | 2022 | 2 | |
| Recorder, Paper Chart | Class 1 | 2022 | 9 | |
| Staple, Removable (Skin) | Class 1 | Disposable skin staplers | 2026 | 20 |
| Stethoscope, Manual | Class 1 | manometer, cuff, cuff bladder, inflation bulb and optioned | 2022 | 64 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 2022 | 98 | |
| System, Monitoring, Perinatal | Class 2 | Tenacore fetal ultrasound and toco transducers | 2021 | 6 |
| System, Network And Communication, Physiological Monitors | Class 2 | 2022 | 4 | |
| System, Pressure Measurement, Intermittent | Class 1 | Non Invasive Blood Pressure Measurement Hose; Reusable NIBP Hose; Connection tube | 2022 | 7 |
| Tape And Bandage, Adhesive | Class 1 | Accessories-Purpose Spo2 sensors securement device; Orantech Y sensor, Nellcor D-YS sensor and Masimo Multi-site sensor | 2022 | 353 |
| Tourniquet, Pneumatic | Class 1 | Accessories of Tourniquet, Pneumatic -Reusable tourniquet Cuffs, Disposable tourniquet Cuffs, air hoses, connectors | 2022 | 21 |
| Transducer, Blood-Pressure, Extravascular | Class 2 | Zhejiang Haisheng compatible DBPT series disposable blood pressure transducer | 2022 | 7 |
| Transducer, Pressure, Intrauterine | Class 2 | 2022 | 2 | |
| Transducer, Ultrasonic, Obstetric | Class 2 | 2022 | 2 | |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | Class 2 | 2022 | 11 | |
| Tubing, Pressure And Accessories | Class 1 | Pressure Hose Assemblies | 2024 | 45 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Orantech | IKD | 1,344 |
| Orantech | DXQ | 648 |
| Orantech | JFC | 215 |
| Orantech | DQA | 97 |
| Orantech | KCY | 35 |
| Orantech | DSA | 15 |
| Reusable NIBP Cuff | DXQ | 9 |
| Orantech | FLL | 8 |
| Orantech | DRX | 7 |
| Orantech | KGX | 6 |
| SpO2 Adapter Cable | DSA | 4 |
| Reusable Temperature Probe | FLL | 4 |
| ECG Leadwires | DSA | 3 |
| One Piece ECG Monitor Cable | DSA | 3 |
| Reusable SpO2 Sensors | DQA | 2 |
| ECG Monitor Trunk Cable | DSA | 2 |
| Invasive BP Adapter Cable | DSA | 2 |
| Disposable SpO2 Sensors | DQA | 1 |
| Orantech | CAI | 1 |
| ETCO2 Sensor | CCK | 1 |
Clearances
5 clearances name Orantech Inc. as applicant. 8 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K182327 | 2019-01-30 | DSA | Traditional | This company |
| K173194 | 2018-10-10 | FLL | Traditional | This company |
| K181270 | 2018-09-07 | DQA | Traditional | This company |
| K173197 | 2018-08-21 | DXQ | Traditional | This company |
| K171828 | 2018-05-31 | CCK | Traditional | This company |
| K233615 | 2024-01-08 | GEI | Traditional | Baisheng Medical Co., Ltd. |
| K203620 | 2021-03-23 | DXQ | Traditional | Wuxi Exanovo Medical Instrument Co., Ltd. |
| K161938 | 2017-05-08 | DQA | Traditional | Xuzhou Yongkang Electronic Science Technology Co., Ltd. |
| K152472 | 2016-10-31 | DRS | Traditional | Zhejiang Haisheng Medical Device Co., Ltd. |
| K140535 | 2014-11-25 | HGM | Abbreviated | Philips Medizin Systeme Boblingen GmbH |
| K081951 | 2008-08-15 | DXQ | Traditional | Wenzhou Kindcare Import & Export Co., Ltd. |
| K002384 | 2000-12-15 | CCL | Abbreviated | International Business Strategies |
| K823670 | 1983-01-12 | GEI | Traditional | Surgicare Scientific Laboratory, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | SpO₂ cables, ECG cables, NIBP cables, Fetal monitoring systems |
|---|---|
| Certifications | ISO13485:2016, FDA, CE |
| Export markets | USA, China, EU |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.