FDA Registration
Active
🇨🇳 China
ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.
Reg #: 3038165043
·
FEI: 3038165043
·
Expires 2026
Products
3
Proprietary Names
0
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- ZYLOX-TONBRIDGE MEDICAL TECHNOLOGY CO., LTD.
- Registration Number
- 3038165043
- FEI Number
- 3038165043
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zylox-Tonbridge Industrial Park, No. 270 Shuyun Road, Yuhang District, Hangzhou, Zhejiang Province, China.
- City
- Hangzhou Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K230594
Owner / Operator
- Firm Name
- Zylox-Tonbridge Medical Technology Co., Ltd.
- Operator Number
- 10094673
- Address
- Zylox-Tonbridge Industrial Park, No. 270 Shuyun Road, Yuhang District, Hangzhou, Zhejiang Province, China.
- City
- Hangzhou
- State
- Zhejiang
- Postal Code
- 311121
- Country
- CN
- Correspondent
- Wenner Xie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | Class 2 | Radiology | No | 2025-12-16 |
| Catheter For Crossing Total Occlusions | PDU | Class 2 | Cardiovascular | No | 2025-12-16 |
| Catheter, Peripheral, Atherectomy | MCW | Class 2 | Cardiovascular | No | 2025-12-16 |
Establishment Types
Manufacture Medical Device