FDA Registration
Active
🇨🇳 China
LEICA MICROSYSTEMS LTD SHANGHAI
Reg #: 3006610913
·
FEI: 3006610913
·
Expires 2026
Products
8
Proprietary Names
34
Establishment Types
2
Classifications
8
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Registration Details
- Registration Name
- LEICA MICROSYSTEMS LTD SHANGHAI
- Registration Number
- 3006610913
- FEI Number
- 3006610913
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Floor 1, 2, 3A, 4A, and 6, Building T20-1 & Room 301, Building T20-5, 258 Jinzang Road
- City
- China (Shanghai) Pilot Free Trade Zone
- Country
- CN
Owner / Operator
- Firm Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Operator Number
- 10054155
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- Postal Code
- 60010
- Country
- US
- Correspondent
- Adam Blunier
US Agent
- Business Name
- Leica Biosystems, division of Leica Microsystems, Inc.
- Contact Name
- Adam Blunier
- Address
- 21440 W. Lake Cook Road, Floor 5
- City
- Deer Park
- State
- IL
- ZIP
- 60010
- Country
- US
- [email protected]
- Phone
- 630 6340069 ext. 3462
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2017-04-26 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2017-02-23 |
| Microtome, Sliding | KFL | Class 1 | Pathology | No | 2017-04-26 |
| Microscope, Fluorescence/U.V. | IBK | Class 1 | Pathology | No | 2017-05-09 |
| Microscope, Inverted Stage, Tissue Culture | IBL | Class 1 | Pathology | No | 2017-05-09 |
| Light, Microscope | IBJ | Class 1 | Pathology | No | 2017-05-09 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2017-04-26 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2017-04-26 |
Proprietary Names
HI1210
HistoCore Water Bath M
ASP300S
HistoCore PEARL
TP1020
PELORIS
Leica PELORIS II
HistoCore PELORIS 3
ASP200S
ASP6025
ASP6025 S
HistoCore PEGASUS
HistoCore PEGASUS Plus
SM2010 R
DMi1
DM3000
DM2000
DM2000 LED
DM1000
DM3000 LED
DM1000 LED
DM2500
DM2500LED
RM2265
RM2235
RM2245
RM2255
HistoCore BIOCUT
RM2125 RTS
HistoCore AUTOCUT
HistoCore MULTICUT
HistoCore NANOCUT
HistoCore Arcadia C
HistoCore Arcadia H
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device