FDA Registration
Active
🇸🇬 Singapore
Leica M525 F20
Reg #: 1000204638
·
FEI: 1000204638
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LEICA INSTRUMENTS (SINGAPORE) PTE LTD.
- Registration Number
- 1000204638
- FEI Number
- 1000204638
- Status
- Active
- Expiry Year
- 2025
- 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 |
|---|---|---|---|---|---|
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2017-05-08 |
Proprietary Names
Leica M525 F20
Leica M320 C12
Leica Wireless Footswitch, 12 Functions
Leica M320 LW12
Leica M320 W12
Leica M320 FP12
Leica M320 TC12
Leica Wireless Footswitch, 14 Functions
Leica M320 F12
Leica M530 OHX
Leica M320 TP12
PROvido
Surgical Microscope Air Removal System (SMARS)
ARveo 8
MyVeo
ARveo 8x
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)