FDA Registration
Active
🇺🇸 United States
Mortara H12+ digital holter recorder
Reg #: 3010082909
·
FEI: 3010082909
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Emsere, Inc.
- Registration Number
- 3010082909
- FEI Number
- 3010082909
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 627 Highway 74 South, Suite 220
- City
- Peachtree City
- State
- GA
- ZIP
- 30269
- Country
- US
Regulatory Submissions
- 510(k) Number
- K021373
Owner / Operator
- Firm Name
- Emsere, Inc
- Operator Number
- 10047331
- Address
- Zaalbergweg 9
- City
- Leiden
- State
- Zuid-Holland
- Postal Code
- 2314XS
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | Class 2 | Cardiovascular | No | 2015-05-18 |
Proprietary Names
Mortara H12+ digital holter recorder
Establishment Types
Repack or Relabel Medical Device