FDA Registration
Active
🇨🇳 China
Fluorescence mode
Reg #: 3032734659
·
FEI: 3032734659
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Carl Zeiss Meditec (Suzhou) Co., Ltd.
- Registration Number
- 3032734659
- FEI Number
- 3032734659
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F, No.26 Wu Sheng Road, SIP
- City
- Suzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171007
Owner / Operator
- Firm Name
- Carl Zeiss Meditec, Inc.
- Operator Number
- 9053564
- Address
- 5300 Central Parkway
- City
- Dublin
- State
- CA
- Postal Code
- 94568
- Country
- US
- Correspondent
- Paul Swift
US Agent
- Business Name
- Carl Zeiss Meditec USA Inc
- Contact Name
- Paul Swift
- Address
- 5300 Central Parkway
- City
- Dublin
- State
- CA
- ZIP
- 94568
- Country
- US
- [email protected]
- Phone
- 817 9258507
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Fluorescence Caries Detection | NBL | Class 2 | Dental | No | 2025-06-18 |
Proprietary Names
Fluorescence mode
Establishment Types
Manufacture Medical Device