FDA Registration
Active
🇨🇳 China
INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.
Reg #: 3015168843
·
FEI: 3015168843
·
Expires 2026
Products
12
Proprietary Names
22
Establishment Types
1
Classifications
12
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Registration Details
- Registration Name
- INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.
- Registration Number
- 3015168843
- FEI Number
- 3015168843
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1011, Liaohe Road, Xinbei District
- City
- Changzhou City Jiangsu
- Country
- CN
Owner / Operator
- Firm Name
- Intersurgical Medical Apparatus (Changzhou) Co., Ltd.
- Operator Number
- 10059558
- Address
- No. 1011, Liaohe Road, Xinbei District
- City
- Changzhou City
- State
- Jiangsu
- Postal Code
- 213125
- Country
- CN
- Correspondent
- Ivan Seniut
US Agent
- Business Name
- Intersurgical Inc
- Contact Name
- Kerrie Campbell
- Address
- 5010 Campuswood Dr, Ste 102
- City
- East Syracuse
- State
- NY
- ZIP
- 13057
- Country
- US
- [email protected]
- Phone
- 315 4512900 ext. 500
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2022-11-07 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2022-05-12 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2023-05-09 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2025-04-21 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2022-05-25 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2022-11-07 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-03-21 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2025-04-21 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2022-05-25 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2022-05-25 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2019-01-31 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-12-21 |
Proprietary Names
high concentration oxygen mask, 1192000
3504000, Superset Straight Connector
Flexible straight catheter mount, 3511000
Flexible fixed elbow catheter mount, 3501000, 3502000
Clear-Guard Midi low volume breathing filter with luer port, 1644000
Smoothbore tube, 5005000, 5018000
2920010, 2920310
2158000
Pulmo-Protect lung function filter
1691011, 1691012, 1691016, 1691013, 1691014, 1691009
1691000, 1691001, 1691002, 1691003, 1691004, 1691005, 1691006, 1691007, 1691050, 1691051, 1691052, 1691053, 1691010
adult high concentration oxygen mask, 1181015
adult medium concentration oxygen mask, 1135015, 1135017, 1136015
Sentri EcoLite, 1141015
Clear-Guard 3 breathing filter, 1544000
Flo-Guard Breathing Filter, 1690000
2731000, 2734000, 2734100, 2725000, 1142015, 1142016, 1143015, 1143017, 1143018
Venturi Valve, 1400024, 1400028, 1400031, 1400035, 1400040, 1400050, 1400060
1691020, Flexible mouthpiece
1691040, Nose clip-plastic, 1435000
1174000, 1174003, 1174021
1161000, 1163000, 1165000, 1165002, 1166000, 1167000
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)