FDA Registration
Active
🇮🇳 India
Apogee Plus Intermittent Catheter
Reg #: 3007185216
·
FEI: 3007185216
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Microtrol Sterilisation Services Pvt. Ltd.
- Registration Number
- 3007185216
- FEI Number
- 3007185216
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot No. 341 Sector 3, Phase ll, HSllDC, IMT Bawal
- City
- Rewari Haryana
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K032710
Owner / Operator
- Firm Name
- Microtrol Sterilisation Services Pvt. Ltd.
- Operator Number
- 10048897
- Address
- 308-309, ATL Corporate Park, Saki Vihar Road
- City
- Mumbai
- State
- Maharashtra
- Postal Code
- 400072
- Country
- IN
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Urological | KOD | Class 2 | Gastroenterology, Urology | No | 2015-03-17 |
Proprietary Names
Apogee Plus Intermittent Catheter
Establishment Types
Export Device to the United States But Perform No Other Operation on Device