FDA Registration
Active
🇨🇳 China
Workmate Claris CI Module
Reg #: 3012260771
·
FEI: 3012260771
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMPHENOL ALDEN PRODUCTS COMPANY
- Registration Number
- 3012260771
- FEI Number
- 3012260771
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 1, No.7, Dongbao Road,, Dongkeng Community, Fenghuang Sub-District, Guangming District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151911
Owner / Operator
- Firm Name
- Amphenol Alden Products Company
- Operator Number
- 10025614
- Address
- 117 N Main Street
- City
- Brockton
- State
- MA
- Postal Code
- 02301
- Country
- US
- Correspondent
- Michael Virusso
US Agent
- Business Name
- AMPHENOL ALDEN PRODUCTS
- Contact Name
- Michael Virusso
- Address
- 117 N. Main Street
- City
- Brockton
- State
- MA
- ZIP
- 02301
- Country
- US
- [email protected]
- Phone
- 508 4277000 ext. 7010
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2018-04-16 |
Proprietary Names
Workmate Claris CI Module
Computer, Diagnostic, Programmable - IBP Cable Truwave; Worknmate Claris CI Module
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)