FDA Registration
Active
🇸🇬 Singapore
LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
Reg #: 1000204638
·
FEI: 1000204638
·
Expires 2026
Products
5
Proprietary Names
35
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
- Registration Number
- 1000204638
- FEI Number
- 1000204638
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 15 TUKANG INNOVATION DRIVE
- City
- SINGAPORE South West
- Country
- SG
Owner / Operator
- Firm Name
- Leica Microsystems CMS GmbH
- Operator Number
- 10054809
- Address
- Ernst-Leitz-Strasse 17-37
- City
- Wetzlar
- State
- Hesse
- Postal Code
- 35578
- Country
- DE
- Correspondent
- Roland Jehle
US Agent
- Business Name
- LEICA MICROSYSTEMS NC, INC.
- Contact Name
- Iris Pohl
- Address
- 4222 Emperor Blvd, Suite 390
- City
- Durham
- State
- NC
- ZIP
- 27703
- Country
- US
- [email protected]
- Phone
- 919 5951274
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2017-05-08 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2017-05-08 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 2017-05-08 |
| Diagnostic Neurosurgical Microscope Filter | QFX | Class 2 | Neurology | No | 2019-04-08 |
| Microscope, Surgical, General & Plastic Surgery | FSO | Class 1 | General, Plastic Surgery | No | 2017-05-08 |
Proprietary Names
Leica FL800
Leica M530 OHX
Leica M320 W12
Leica M320 C12
Leica M320 TC12
Leica Wireless Footswitch, 12 Functions
Leica M525 F20
Leica M320 LW12
Leica M320 TP12
Leica M320 FP12
Leica Wireless Footswitch, 14 Functions
Leica M320 F12
Surgical Microscope Air Removal System (SMARS)
PROvido
ARveo 8
MyVeo
ARveo 8x
Leica ToricEyePiece
PROVEO 8 F42
Leica RUV800 WD175
Leica M822 CT40
Leica M822 F20
Leica M822 F40
Leica RUV800 WD200
PROVEO 8 CT42
PROVEO 8x
GLOW800
Leica FL800 ULT
Leica FL400
Leica FL560
Leica FL560 Procedure Kit
Leica M844 F40
Leica M844 F20
Leica M220 F12
Leica M844 CT40
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)