Intersurgical Medical Apparatus (Changzhou) Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 12 device types.
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clip, Nose, Mask, Oxygen and 10 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015168843 |
| FEI number | 3015168843 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 1011, Liaohe Road, Xinbei District |
| Postal code | 213125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | Class 2 | 2731000, 2734000, 2734100, 2725000, 1142015, 1142016, 1143015, 1143017, 1143018 | 2023 | 29 |
| Cannula, Nasal, Oxygen | Class 1 | 1161000, 1163000, 1165000, 1165002, 1166000, 1167000 | 2020 | 97 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | Class 1 | 2920010, 2920310, 2158000, Smoothbore tube, 5005000, 5018000 | 2025 | 55 |
| Clip, Nose | Class 1 | 1691040, Nose clip-plastic, 1435000 | 2022 | 17 |
| Connector, Airway (Extension) | Class 1 | 3504000, Superset Straight Connector, Flexible straight catheter mount, 3511000, Flexible fixed elbow catheter mount, 3501000, 3502000 | 2022 | 20 |
| Filter, Bacterial, Breathing-Circuit | Class 2 | Flo-Guard Breathing Filter, 1690000, Clear-Guard Midi low volume breathing filter with luer port, 1644000, Clear-Guard 3 breathing filter, 1544000 | 2022 | 15 |
| Mask, Oxygen | Class 1 | adult medium concentration oxygen mask, 1135015, 1135017, 1136015, Sentri EcoLite, 1141015, adult high concentration oxygen mask, 1181015 | 2022 | 126 |
| Mask, Oxygen, Low Concentration, Venturi | Class 1 | Venturi Valve, 1400024, 1400028, 1400031, 1400035, 1400040, 1400050, 1400060 | 2025 | 46 |
| Mask, Oxygen, Non-Rebreathing | Class 1 | high concentration oxygen mask, 1192000 | 2022 | 72 |
| Mouthpiece, Breathing | Class 1 | 1691020, Flexible mouthpiece | 2022 | 67 |
| Spirometer, Diagnostic | Class 2 | 1691000, 1691001, 1691002, 1691003, 1691004, 1691005, 1691006, 1691007, 1691050, 1691051, 1691052, 1691053, 1691010, 1691011, 1691012, 1691016, 1691013, 1691014, 1691009, Pulmo-Protect™ lung function filter | 2022 | 10 |
| Tubing, Pressure And Accessories | Class 1 | 1174000, 1174003, 1174021 | 2019 | 45 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Airway management devices, Anaesthesia equipment, Critical care products, Oxygen therapy devices, Resuscitation equipment |
| Certifications | ISO quality standards, EcoVadis Bronze Medal |
| Export markets | Global |
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.