FDA Registration
Active
🇨🇳 China
2731000, 2734000, 2734100, 2725000, 1142015, 1142016, 1143015, 1143017, 1143018
Reg #: 3015168843
·
FEI: 3015168843
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INTERSURGICAL MEDICAL APPARATUS (CHANGZHOU) CO., LTD.
- Registration Number
- 3015168843
- FEI Number
- 3015168843
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No. 1011, Liaohe Road, Xinbei District
- City
- Changzhou City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K122075
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 |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2023-03-21 |
Proprietary Names
2731000, 2734000, 2734100, 2725000, 1142015, 1142016, 1143015, 1143017, 1143018
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)