FDA Registration
Active
🇩🇰 Denmark
SAGE Vitrification Kit
Reg #: 3004048494
·
FEI: 3004048494
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORIGIO A/S
- Registration Number
- 3004048494
- FEI Number
- 3004048494
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Knardrupvej 2
- City
- Malov Hovedstaden
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K170560
Owner / Operator
- Firm Name
- ORIGIO A/S
- Operator Number
- 9012179
- Address
- Knardrupvej 2, --
- City
- Malov
- State
- DK-NOTA
- Postal Code
- 2760
- Country
- DK
- Correspondent
- Brith Nordberg
US Agent
- Business Name
- Senior Director of Pharmacovigilance & Laboratory Compliance
- Contact Name
- Mauro Castro
- Address
- CooperSurgical Inc., 95 Corporate Drive
- City
- Trumbull
- State
- CT
- ZIP
- 06611
- Country
- US
- [email protected]
- Phone
- 203 6120854
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Media, Reproductive | MQL | Class 2 | Obstetrics/Gynecology | No | 2017-04-05 |
Proprietary Names
SAGE Vitrification Kit
SAGE Vitrification Warming Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility