FDA Registration
Active
🇮🇳 India
Annalise Critical Care AI - Vasogenic Edema
Reg #: 3034396442
·
FEI: 3034396442
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Annalise-AI India Pte Ltd
- Registration Number
- 3034396442
- FEI Number
- 3034396442
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Aneja Towers, 4th Floor Block A, Plot 4 & 5 Developed Plot Estate, OMR Perungudi
- City
- Chennai Tamil Nadu
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K231767
Owner / Operator
- Firm Name
- Annalise-AI
- Operator Number
- 10085806
- Address
- Level P, 24 Campbell St
- City
- Sydney
- State
- New South Wales
- Postal Code
- 2000
- Country
- AU
US Agent
- Business Name
- Qserve Group US Inc.
- Contact Name
- Mindy McCann
- Address
- 350 S Main St Ste 309
- City
- Doylestown
- State
- PA
- ZIP
- 18901
- Country
- US
- [email protected]
- Phone
- 424 2718169
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | Class 2 | Radiology | No | 2023-11-05 |
Proprietary Names
Annalise Critical Care AI - Vasogenic Edema
Annalise Critical Care AI
Annalise Triage - Vasogenic Edema
Annalise - Vasogenic Edema
Annalise Triage CTB
Annalise Triage
Establishment Types
Manufacture Medical Device