FDA Registration
Active
🇮🇳 India
XCELLANCE MEDICAL TECHNOLOGIES PVT. LTD.
Reg #: 3011580044
·
FEI: 3011580044
·
Expires 2026
Products
9
Proprietary Names
64
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- XCELLANCE MEDICAL TECHNOLOGIES PVT. LTD.
- Registration Number
- 3011580044
- FEI Number
- 3011580044
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Shalya Avenue, Plot No. W-237, W-238(A) & W-239, T.T.C. Industrial Area, M.I.D.C., Rabale
- City
- Navi Mumbai Maharashtra
- Country
- IN
Owner / Operator
- Firm Name
- XcelLance Medical Technologies Pvt. Ltd.
- Operator Number
- 10057918
- Address
- Shalya Avenue, Plot No. W-237, W-238(A) & W-239, T.T.C., Industrial Area, M.I.D.C., Rabale
- City
- Navi Mumbai
- State
- Maharashtra
- Postal Code
- 400701
- Country
- IN
US Agent
- Business Name
- QA/RA CONSULTING GROUP, INC.
- Contact Name
- Scott Bednar
- Address
- 3335 Tuscarawas Rd
- City
- Beaver
- State
- PA
- ZIP
- 15009
- Country
- US
- [email protected]
- Phone
- 412 4188066
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2018-06-16 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2023-12-09 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2018-06-18 |
| Device, Digital Image Storage, Radiological | LMB | Class 1 | Radiology | No | 2023-12-09 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2018-06-13 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2023-12-09 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2023-12-09 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2018-06-16 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2024-11-14 |
Proprietary Names
Shalya EndoLUX: EndoLUX P
Shalya EndoLUX: EndoLUX D
Shalya EndoLUX: EndoLUX e
Shalya Flex 500 N
Shalya Flex 500
Shalya Flex 500 E (without top sliding)
Shalya Flex 200 (Advance)
Shalya Flex 500 Es (with top sliding)
Shalya Flex 200 E
Shalya Flex 500 Pro
Shalya iLUX Mobile Surgical Light System: iLUX 10 M
Shalya iLUX Mobile Surgical Light System: iLUX 40-40 M
Shalya iLUX Mobile Surgical Light System: iLUX 10-20 M
Shalya iLUX Mobile Surgical Light System: iLUX 20 M
Shalya iLUX Mobile Surgical Light System: iLUX 10-10 M
Shalya iLUX Mobile Surgical Light System: iLUX 10-40 M
Shalya iLUX Mobile Surgical Light System: iLUX 20-40 M
Shalya iLUX Mobile Surgical Light System: iLUX 20-20 M
Shalya ReCo FHD
Shalya ReCo UHD
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-40 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-20 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20-20 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 10-10 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20-40 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 20 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 40-40 O
Shalya iLUX Central Axis 360 Degree Surgical Light System: iLUX 40 O
Irrigation Trolley
Laparoscopic Trolley
Basic ESU Trolley
Console Trolley
Shalya Integra
Argon Trolley
Surgical Pendant
ICU Pendant
Horizontal Pendant
Anesthesia Pendant
Endoscopy Pendant
Hybrid Pendant
Shalya iLUX Surgical Light with Camera- Display system: iLUX 20-20 M/W/O/C-D
Shalya iLUX Wall Mount Surgical Light System: iLUX 20-40 W
Shalya iLUX Surgical Light with Camera- Display system: iLUX 20-40 M/W/O/C-D
Shalya iLUX Surgical Light with Camera- Display system: iLUX 40-40 M/W/O/C-D
Shalya iLUX Surgical Light with Camera System: iLUX 40 O/C
Shalya iLUX Wall Mount Surgical Light System: iLUX 40-40 W
Shalya iLUX Surgical Light with Camera- Display system: iLUX 10-20 M/W/O/C-D
Shalya iLUX Wall Mount Surgical Light System: iLUX 10-40 W
Shalya iLUX Wall Mount Surgical Light System: iLUX 20 W
Shalya iLUX Wall Mount Surgical Light System: iLUX 20-20 W
Shalya iLUX Wall Mount Surgical Light System: iLUX 10-10 W
Shalya iLUX Surgical Light with Camera- Display system: iLUX 10-40 M/W/O/C-D
Shalya iLUX Surgical Light with Camera System: iLUX 20 M/W/O/C
Shalya iLUX Wall Mount Surgical Light System: iLUX 10 W
Shalya iLUX Wall Mount Surgical Light System: iLUX 10-20 W
Shalya Oculus FHD, Head
Shalya Oculus UHD+
Shalya Oculus QHD
Shalya Oculus FHD
Shalya Oculus UHD
Shalya Oculus UHD, Head
Shalya Oculus UHD+, Head
Shalya Oculus QHD, Head
Establishment Types
Manufacture Medical Device