FDA Registration
Active
🇨🇳 China
Zibo Intco Medical Products Company Limited
Reg #: 3008191396
·
FEI: 3008191396
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- Zibo Intco Medical Products Company Limited
- Registration Number
- 3008191396
- FEI Number
- 3008191396
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18 Qingtian Road, Qilu Chem. Ind. Park,, Linzi
- City
- Zibo Shandong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K132637
Owner / Operator
- Firm Name
- Zibo Intco Medical Products Company Limited
- Operator Number
- 10031179
- Address
- 18 Qingtian Road, Qilu Chem. Ind. Park, Linzi
- City
- Zibo
- State
- Shandong
- Postal Code
- 255414
- Country
- CN
- Correspondent
- John Zhao
US Agent
- Business Name
- Primemax
- Contact Name
- Max Li
- Address
- 805 Barrington Ave
- City
- Ontario
- State
- CA
- ZIP
- 91764
- Country
- US
- [email protected]
- Phone
- 909 9801678
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2014-06-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2021-06-24 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-05-21 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2020-05-21 |
Proprietary Names
Powder-Free Vinyl Patient Examination Gloves, Yellow Color
Face Shields
Isolation Gown
Synmax Synthetic Examination Vinyl Gloves, Powder Free, Blue
Vinyl Examination Glove, Powder Free,
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device