FDA Registration
Active
🇨🇳 China
Disposable Ureteral Guide Sheath
Reg #: 3016690337
·
FEI: 3016690337
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED
- Registration Number
- 3016690337
- FEI Number
- 3016690337
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241181
Owner / Operator
- Firm Name
- Dongguan ZSR Biomedical Technology Company Limited
- Operator Number
- 10092849
- Address
- Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA
- City
- Dongguan
- State
- Guangdong
- Postal Code
- 523651
- Country
- CN
- Correspondent
- Sharon Wen
US Agent
- Business Name
- ZYPPEL LLC
- Contact Name
- Qihui Zhang
- Address
- 1337 Massachusetts Ave Pmb 158
- City
- Arlington
- State
- MA
- ZIP
- 02476
- Country
- US
- [email protected]
- Phone
- 617 2991655
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2025-02-26 |
Proprietary Names
Disposable Ureteral Guide Sheath
Establishment Types
Manufacture Medical Device