FDA Registration
Active
🇩🇰 Denmark
PICO70
Reg #: 8021538
·
FEI: 3002091543
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CODAN MEDICAL APS.
- Registration Number
- 8021538
- FEI Number
- 3002091543
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- FAERGEVEJ 4
- City
- ROEDBY Sjalland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K962158
Owner / Operator
- Firm Name
- CODAN Medical ApS
- Operator Number
- 10046011
- Address
- Faergevej 4
- City
- Roedby
- State
- Sjalland
- Postal Code
- 4970
- Country
- DK
- Correspondent
- Anders Sulbaek
US Agent
- Business Name
- CODAN US CORP.
- Contact Name
- Sam Yu
- Address
- 3501 WEST SUNFLOWER AVE.
- City
- Santa Ana
- State
- CA
- ZIP
- 92704
- Country
- US
- [email protected]
- Phone
- 714 5452111
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2024-04-04 |
Proprietary Names
PICO70
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)