FDA Registration
Active
🇮🇳 India
Sterile Cocoon Convective Warming System
Reg #: 3034393266
·
FEI: 3034393266
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Geelong Healthcare Manufacturing Pvt Ltd
- Registration Number
- 3034393266
- FEI Number
- 3034393266
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- AV-27 GIDC Sanand II, BOL Sanand,
- City
- Ahmedabad Gujarat
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K181671
Owner / Operator
- Firm Name
- CARE ESSENTIALS PTY LTD
- Operator Number
- 10048196
- Address
- 103 Mornington Street
- City
- North Geelong
- State
- Victoria
- Postal Code
- 3215
- Country
- AU
- Correspondent
- ABHAY SINHA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Thermal Regulating | DWJ | Class 2 | Cardiovascular | No | 2019-05-06 |
Proprietary Names
Sterile Cocoon Convective Warming System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)