FDA Registration
Active
🇩🇪 Germany
SLEE MEDICAL GMBH
Reg #: 3008399755
·
FEI: 3008399755
·
Expires 2026
Products
11
Proprietary Names
28
Establishment Types
6
Classifications
11
Registration Details
- Registration Name
- SLEE MEDICAL GMBH
- Registration Number
- 3008399755
- FEI Number
- 3008399755
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Am Neuberg 14
- City
- Nieder-Olm Rhineland-Palatinate
- Country
- DE
Owner / Operator
- Firm Name
- SLEE medical GmbH
- Operator Number
- 10055938
- Address
- Nieder-Olm
- City
- Nieder-Olm
- State
- Rhineland-Palatinate
- Postal Code
- 55268
- Country
- DE
- Correspondent
- Alexander Schaumburg
US Agent
- Business Name
- Mercedes Medical
- Contact Name
- Misty McWhorter-Darley
- Address
- 12210 Rangeland Parkway
- City
- Lakewood Ranch
- State
- FL
- ZIP
- 34211
- Country
- US
- [email protected]
- Phone
- 941 3553333 ext. 110
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2017-10-20 |
| Table, Slide Warming | IEG | Class 1 | Pathology | No | 2017-10-20 |
| Stainer, Tissue, Automated | KEY | Class 1 | Pathology | No | 2018-01-29 |
| Device For Sealing Microsections | KIM | Class 1 | Pathology | No | 2025-09-15 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2017-10-19 |
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2021-10-22 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2017-11-06 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2018-01-29 |
| Cytocentrifuge | IFB | Class 1 | Pathology | No | 2019-09-27 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2017-10-19 |
| Quality Control Slides | LJG | Class 1 | Microbiology | No | 2019-01-21 |
Proprietary Names
SLEE MPS/CX
SLEE MPS/P1
SLEE MPS/WH
SLEE MPS/P2
SLEE MPS/W
SLEE MPS/P
SLEE MPS/C
SLEE slidetec Water
SLEE slidetec Heat
SLEE slidetec Water/Heat
MAS Automated tissue stainer
cromatec
Covertec Tape Coverslipper
Floorstanding cryostat MNT
Floorstanding cryostat MEV
Aquatec
MTP I & II carousel tissue processor
MTM I & II fast tissue processor
printtec slide
printtec cassette
CS CENTRIFUGE I
CS CENTRIFUGE II
SLEE CUT 6062
SLEE CUT 4062
SLEE CUT 5062
printec Autoloader
printtec c / Cassette
printtec s / slide
Establishment Types
Foreign Private Label Distributor
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device