FDA Registration
Active
🇩🇪 Germany
MEDITE MEDICAL GMBH
Reg #: 3004594181
·
FEI: 3004594181
·
Expires 2026
Products
24
Proprietary Names
48
Establishment Types
1
Classifications
24
Registration Details
- Registration Name
- MEDITE MEDICAL GMBH
- Registration Number
- 3004594181
- FEI Number
- 3004594181
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Wollenweberstr. 12
- City
- Burgdorf Lower Saxony
- Country
- DE
Owner / Operator
- Firm Name
- MEDITE Medical GmbH
- Operator Number
- 10088477
- Address
- Wollenweberstr. 12
- City
- Burgdorf
- State
- Lower Saxony
- Postal Code
- 31303
- Country
- DE
- Correspondent
- Michael E Ott
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Formulations, Paraffin, All | KEO | Class 1 | Pathology | No | 2023-08-18 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 2023-08-18 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2023-07-29 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2023-08-18 |
| Container, Specimen Mailer And Storage, Non-Sterile | NNK | Class 1 | Pathology | No | 2023-08-18 |
| Processor, Tissue, Automated | IEO | Class 1 | Pathology | No | 2023-07-29 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2023-07-29 |
| Ovens, Paraffin | IDR | Class 1 | Pathology | No | 2023-07-29 |
| Device, Accessory, Cooling Plate For Tissue Embedding Station | MXT | Class 1 | Pathology | No | 2023-07-29 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2023-08-18 |
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2023-07-29 |
| Mounting Media | LEB | Class 1 | Pathology | No | 2023-08-18 |
| Device, Decalcifier, Electrolytic | KDZ | Class 1 | Pathology | No | 2023-07-29 |
| Agent, Clearing | KEM | Class 1 | Pathology | No | 2023-08-18 |
| Slide Stainer, Immersion Type | KIO | Class 1 | Pathology | No | 2023-08-18 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 2023-07-29 |
| Dispensers, Paraffin | IDW | Class 1 | Pathology | No | 2023-07-29 |
| Microtome, Rotary | IDO | Class 1 | Pathology | No | 2023-07-29 |
| Container, Embedding | KER | Class 1 | Pathology | No | 2023-07-29 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2023-07-29 |
| Container, Specimen, Non-Sterile | NNI | Class 1 | Pathology | No | 2023-08-18 |
| Table, Slide Warming | IEG | Class 1 | Pathology | No | 2023-07-29 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2023-08-18 |
| Solution, Decalcifier, Acid Containing | KDX | Class 1 | Pathology | No | 2023-08-18 |
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
M630
MEDITE Cryostat
Clear Margin+
SureThin sample vials with fixative solution, Safe Prep sample vials with fixative solution
MEDITE Stretching Table
OTS 40.1520, OTS 40.1540, OTS 40.2025, OTS 40.2530, OTS 40.3040
SureThin Gyn filter (pink), SureThin Non-Gyn filter (blue), SureThin Urine filter
USERAPID Decalcifying Solution, USEDECALC Decalcifying Solution
Establishment Types
Manufacture Medical Device