FDA Registration
Active
🇮🇳 India
MERIL HEALTHCARE PVT. LTD.
Reg #: 3010846112
·
FEI: 3010846112
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- MERIL HEALTHCARE PVT. LTD.
- Registration Number
- 3010846112
- FEI Number
- 3010846112
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Meril Campus, B. No. 8-F1, B. No. 10 B. No. 5-F0, B. No. 6-F2, Muktanand Marg
- City
- Vapi Gujarat
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K171320
Owner / Operator
- Firm Name
- Meril Healthcare Pvt. Ltd.
- Operator Number
- 10049149
- Address
- Meril Campus, B. No. 8-F1, B. No. 10 B. No. 5-F0, B. No. 6-F2, Muktanand Marg
- City
- Vapi
- State
- Gujarat
- Postal Code
- 396191
- Country
- IN
- Correspondent
- Umesh Sharma
US Agent
- Business Name
- Meril Inc.
- Contact Name
- Kaiyumkhan Patel
- Address
- 2436, Emrick Boulevard, Bethlehem
- City
- Bethlehem
- State
- PA
- ZIP
- 18020
- Country
- US
- [email protected]
- Phone
- 267 5158405
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-07-19 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-07-19 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-11-04 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-07-25 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-03-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-03-13 |
Proprietary Names
ARMAR
MBOSS
FIXION
ARTIS
MARSH
Destiknee
Freedom® CR Femoral Component
FREEDOM(R) STEMMED TIBIAL COMPONENTS
Latitud
Freedom® Total Knee System
Freedom (R) PCK Components
Opulent - TiNbN Coated Knee
Freedom® Metal Backed Tibial Component
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)