Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004594181

FEI Number

3004594181

Entity Name

MEDITE MEDICAL GMBH

City/State/Country

Burgdorf Lower Saxony, DE

Establishment Address

Wollenweberstr. 12, Burgdorf Lower Saxony 31303, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEDITE Medical GmbH (Owner Number: 10088477)

Owner / Operator Contact Address

Wollenweberstr. 12, Burgdorf, DE-NI 31303, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MEDITE PURE Paraffin Safe Prep staining set MEDITE Glass coverslipper combination, Film Coverslipper Twister Cover Film ACS 720, Twister 20, Twister 30 Filmstar Stainer-Film-Coverslipper System Type R 70 High Profile Type LS35 Low Profile Plasma, Type LH35 Low Profile Plasma, Type R 52 Low Profile, Type N 42 Low Profile Microscope Slide Folder 51.850042, Large specimen processing basket for Sakura Tissue-Tek VIP Specimen processing basket standard for older Sakura Tissue Processors Microscope Slide Board 51.850033, Microscope Slide Box 52.850.723, Microscope Slide Box 52.850.724 Small specimen processing basket for Sakura Tissue-Tek VIP MEDITE Tissue Processing System TPC 12 Uno TPC 12 Duo MEDITE Fume Absorber, Fume Hood, Heated Forceps TAZ 19.100, TAZ 19.300, TAZ 19.500, Path Hood, eCEP 0.5mm, eCEP 1mm, eCEP 2mm, eCEP 4mm MCP 450 Casette Printer, MCP 075 Casette Printer, MSP 150 Slide Printer TDO Sahara MEDITE Tissue Drying Oven MEDITE Cooling Plate, Cooling Unit COP 30, TKF 22 Cryolith S SureThin Microscope slides with white circle, Coverglass for Automats, Safe Prep microscope slides MEDITE Tissue Floatation Bath, Section Transfer System TFB 35.100, TFB 35.600, TFB 45, TFB 55, AQ540 SureThin Fixative solution for gynaecological applications, SureThin Lysis solution for non-gynaecological application Safe Prep density gradient fluid USE 33 MEDITE Ultrasonic Decalcifying Automat CitEX Paraffin Remover Large, Medium, Small (12, 6, 3 staining stations) MEDITE Cytology sample preparing Sure Thin Processor MEDITE Paraffin Dispenser L15 A550, M380, M530, S180 MEDITE Microtome TES 99.41, TES 99.42, TES 99.6, TES 99.25 MEDITE Paraffin Embedding System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KEO	Formulations, Paraffin, All	Pathology	Class 1	864.4010	2023-08-18
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2023-08-18
KES	Coverslips, Microscope Slide	Pathology	Class 1	864.3010	2023-07-29
IDL	Microtome, Accessories	Pathology	Class 1	864.3010	2023-08-18
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2023-08-18
IEO	Processor, Tissue, Automated	Pathology	Class 1	864.3875	2023-07-29
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2023-07-29
IDR	Ovens, Paraffin	Pathology	Class 1	864.3010	2023-07-29
MXT	Device, Accessory, Cooling Plate For Tissue Embedding Station	Pathology	Class 1	864.3010	2023-07-29
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2023-08-18
IDY	Bath, Flotation, Tissue	Pathology	Class 1	864.3010	2023-07-29
LEB	Mounting Media	Pathology	Class 1	864.4010	2023-08-18
KDZ	Device, Decalcifier, Electrolytic	Pathology	Class 1	864.3010	2023-07-29
KEM	Agent, Clearing	Pathology	Class 1	864.4010	2023-08-18
KIO	Slide Stainer, Immersion Type	Pathology	Class 1	864.3800	2023-08-18
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2023-07-29
IDW	Dispensers, Paraffin	Pathology	Class 1	864.3010	2023-07-29
IDO	Microtome, Rotary	Pathology	Class 1	864.3010	2023-07-29
KER	Container, Embedding	Pathology	Class 1	864.3010	2023-07-29

Official Correspondent

Michael Ott

US Agent Details

Mohsen Aminipour Email: info@fdalisting.com Phone: (646) 5124798

Related Public Records

Same Entity

MEDITE 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-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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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3010420046	CITOTEST Labware Manufacturing CO., LTD.	Haimen Jiangsu, CN
3010973832	TRAJAN SCIENTIFIC AUSTRALIA PTY LTD	Ringwood Victoria, AU
3013182314	POTH HILLE & CO LTD	Rainham Essex, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004594181. Last updated year: 2026. Please use registration number 3004594181 when referencing this establishment in official correspondence.