FDA Registration
Active
🇳🇱 Netherlands
COOL INCUBATOR 23 120V; COOL TOWER 23 120V; INCUBATOR 10 120V; INCUBATOR 10 Analog 120V; INCUBATOR 23 120V; INCUBATOR 56 120V; WATER BATH 6 120V
Reg #: 3010381606
·
FEI: 3010381606
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- EMSERE BV
- Registration Number
- 3010381606
- FEI Number
- 3010381606
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Zaalbergweg 9
- City
- Leiden Zuid-Holland
- Country
- NL
Owner / Operator
- Firm Name
- Emsere, Inc
- Operator Number
- 10047331
- Address
- Zaalbergweg 9
- City
- Leiden
- State
- Zuid-Holland
- Postal Code
- 2314XS
- Country
- NL
- Correspondent
- Patrice Gerard
US Agent
- Business Name
- Emsere, Inc.
- Contact Name
- Nick Floars
- Address
- 627 Highway 74 South, Suite 220
- City
- Peachtree City
- State
- GA
- ZIP
- 30269
- Country
- US
- [email protected]
- Phone
- 770 8383959
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Incubators/Water, All | JTQ | Class 1 | Microbiology | No | 2025-01-23 |
Proprietary Names
COOL INCUBATOR 23 120V; COOL TOWER 23 120V; INCUBATOR 10 120V; INCUBATOR 10 Analog 120V; INCUBATOR 23 120V; INCUBATOR 56 120V; WATER BATH 6 120V
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device