FDA Registration
Active
🇩🇪 Germany
LEICA BIOSYSTEMS NUSSLOCH GMBH
Reg #: 8010478
·
FEI: 3002179321
·
Expires 2026
Products
9
Proprietary Names
61
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Registration Number
- 8010478
- FEI Number
- 3002179321
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- HEIDELBERGER STR. 17-19
- City
- NUSSLOCH Baden-Wurttemberg
- Country
- DE
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 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2017-04-24 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2017-04-26 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2017-02-17 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2017-02-23 |
| Microtome, Sliding | KFL | Class 1 | Pathology | No | 2017-04-26 |
| Slide Stainer, Automated | KPA | Class 1 | Pathology | No | 2017-02-23 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2017-04-26 |
| Device For Sealing Microsections | KIM | Class 1 | Pathology | No | 2017-04-21 |
Proprietary Names
HI1210
HistoCore Water Bath M
CM1520
CM1860
CM1100
CM1950
CM3050 S
CM1860UV
HistoCore Arcadia C
HistoCore Arcadia H
Low-Profile Disposable Blades DB80LS (10x50)
Low-Profile Disposable Blades 819 (1x50)
Low-Profile Disposable Blades DB80LX (10x50)
Low-Profile Disposable Blades DB80LX (1x50)
High-Profile Disposable Blades DB80HS (10x50)
High-Profile Disposable Blades 818
Low-Profile Disposable Blades DB80LS (1x50)
High-Profile Disposable Blades 818 (10x50)
High-Profile Disposable Blades DB80HS (1x50)
Low-Profile Disposable Blades 819 (10x50)
Coated Low Profile Microtome Blades
High Profile Thin Microtome Blades
Triple Facet/Low Profile/Microtome Blades
High Profile Thick Microtome Blades
Coated High Profile Microtome Blades
ASP300S
HistoCore PEARL
TP1020
PELORIS
Leica PELORIS II
HistoCore PELORIS 3
ASP200S
ASP6025
ASP6025 S
HistoCore PEGASUS
HistoCore PEGASUS Plus
SM2010 R
HistoCore SPECTRA ST
Leica BOND-MAX
ST5020
ST4020
Leica BOND-III
ST5010 (Autostainer XL)
BOND-PRIME
BOND Titration Container Inserts
HistoCore CHROMAX ST
BOND Titration Kit
BOND Open Containers 30mL
BOND Open Containers 7mL
RM2265
RM2235
RM2245
RM2255
HistoCore BIOCUT
RM2125 RTS
HistoCore AUTOCUT
HistoCore MULTICUT
HistoCore NANOCUT
CV5030
HistoCore SPECTRA CV
HistoCore CHROMAX CV
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Foreign Private Label Distributor