Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008399755

FEI Number

3008399755

Entity Name

SLEE MEDICAL GMBH

City/State/Country

Nieder-Olm Rhineland-Palatinate, DE

Establishment Address

Am Neuberg 14, Nieder-Olm Rhineland-Palatinate 55268, DE

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

SLEE medical GmbH (Owner Number: 10055938)

Owner / Operator Contact Address

Nieder-Olm, Nieder-Olm, DE-RP 55268, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2017-10-20
IEG	Table, Slide Warming	Pathology	Class 1	864.3010	2017-10-20
KEY	Stainer, Tissue, Automated	Pathology	Class 1	864.3800	2018-01-29
KIM	Device For Sealing Microsections	Pathology	Class 1	864.3400	2025-09-15
IDP	Microtome, Cryostat	Pathology	Class 1	864.3010	2017-10-19
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2021-10-22
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2017-11-06
IDZ	Cassettes, Tissue	Pathology	Class 1	864.3010	2018-01-29
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2019-09-27
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2017-10-19

Official Correspondent

Alexander Schaumburg

US Agent Details

Misty McWhorter-Darley Business: Mercedes Medical Email: Mmcwhorter@mercedesmedical.com Phone: (941) 3553333

Related Public Records

Same Entity

SLEE medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2019	Leica Microsystems, Inc.	1	Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Z-0039-2012	Richard-Allan Scientific Company	1	Thermo Scientific Microm: Rotary Microtome: REF HM355S-3 Used for slicing tissue blocks.

Similar Registrations

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1000391282	MILESTONE S.P.A.	Sorisole Bergamo, IT
3005787343	CELLPATH LTD	NEWTOWN Powys, GB
3016764932	ZHEJIANG GENE SCIENCE CO., LTD	shaoxing Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008399755. Last updated year: 2026. Please use registration number 3008399755 when referencing this establishment in official correspondence.