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Sign in to claim this brandWhat Leica Biosystems Nussloch GmbH makes
Leica Biosystems Nussloch GmbH produces automated and semi-automated tissue processors for in vitro diagnostic (IVD) use, designed to prepare tissue samples for histological analysis. Their portfolio also includes microscope slide stainers, slide coverslips, and associated consumables such as adapter racks, flexible tubes, and vessel holders for laboratory workflows. Additional accessories like adapter kits, base plates, and output racks support integration with their processing and staining systems.
The company’s devices fall under Class I regulatory classification in the FDA’s Unique Device Identifier (UDI) system, indicating low-risk medical instruments. These products are listed in the FDA’s UDI database, ensuring traceability and compliance with U.S. regulatory requirements. The manufacturer operates from a base in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- leicabiosystems.com
- —
- —
- [email protected]
- Phone
- +4962241430
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 315539452
Catalogue (86)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kit Adapter Rack 30 SPECTRA ST | 000000014047855522 | FDA UDI | Class I | Active |
| Flexible tube 50x2000 | 000000014042231974 | FDA UDI | Class I | Active |
| Flexible tube 50x4000 | 000000014042231975 | FDA UDI | Class I | Active |
| Base plate for workstation | 000000014047537647 | FDA UDI | Class I | Active |
| Output rack 20, pack of 6 | 000000014047840117 | FDA UDI | Class I | Active |
| Leica ST5020 Config.2 | 14905020EU1 | FDA UDI | Class I | Active |
| Vessel Holder Assembly | 000000014047534548 | FDA UDI | Class I | Active |
| Adapter Shandon | 000000014047534518 | FDA UDI | Class I | Active |
| Leica ASP300 S - China | 000000014047643057 | FDA UDI | Class I | Active |
| Adapter Kit for Water Inlet Hose | 000000014050946444 | FDA UDI | Class I | Active |
| Adapter - Medite 20 | 000000014047534516 | FDA UDI | Class I | Active |
| Leica TP1020 (Double loading) With vacuum/ without fume control | 000000014042231414 | FDA UDI | Class I | Active |
| Special stain insert | 000000014051249261 | FDA UDI | Class I | Active |
| Retaining device P for wax station | 000000014042230571 | FDA UDI | Class I | Active |
| ASP6025 S China | 000000014049559088 | FDA UDI | Class I | Active |
| TP1020 (Single loading) With fume control | 000000014042230537 | FDA UDI | Class I | Active |
| Axl 230-240/50-60 Ts5015 | 000000014045638879 | FDA UDI | Class I | Active |
| Lid, slotted | 000000014047534486 | FDA UDI | Class I | Active |
| Leica TP1020 (Single loading) with vacuum/ without fume control | 000000014042230536 | FDA UDI | Class I | Active |
| Extraction tube | 000000014049544881 | FDA UDI | Class I | Active |
| Rack holder, assy. | 000000014045635434 | FDA UDI | Class I | Active |
| Tissue basket - Cone | 000000014042232564 | FDA UDI | Class I | Active |
| Leica ST5020, Basic Instrument | 000000014047533623 | FDA UDI | Class I | Active |
| Rack Special Stainings | 000000014047534524 | FDA UDI | Class I | Active |
| Basket, assy., large | 000000014047634782 | FDA UDI | Class I | Active |
| Lid for 12 vessels | 000000014047533644 | FDA UDI | Class I | Active |
| Adapter - Sakura | 000000014047534515 | FDA UDI | Class I | Active |
| Leica TP1020 (Double loading) With fume control | 000000014042231416 | FDA UDI | Class I | Active |
| Slide rack 20, type Sakura, plastic | 000000014047433463 | FDA UDI | Class I | Active |
| Optional Plexiglas Hood | 000000014050946478 | FDA UDI | Class I | Active |
| Basket set Leica ASP300 S | 000000014047643576 | FDA UDI | Class I | Active |
| Filter cartridge RLN Micro | 000000014047545523 | FDA UDI | Class I | Active |
| Adapter - Medite 30 | 000000014047534517 | FDA UDI | Class I | Active |
| Leica TS5025 - Transfer Station | 000000014047839710 | FDA UDI | Class I | Active |
| Bath insert Medite/Hacker 20/40 | 000000014047839781 | FDA UDI | Class I | Active |
| Tissue basket - three-level | 000000014042230547 | FDA UDI | Class I | Active |
| Adapter for large slides | 000000014045627069 | FDA UDI | Class I | Active |
| Leica TP1020 (Double loading) Without vaccum/w | 000000014042231418 | FDA UDI | Class I | Active |
| Kit Cover plate for Cuvettes (pack of 3) | 000000014051257846 | FDA UDI | Class I | Active |
| Preparation basket | 000000014042230622 | FDA UDI | Class I | Active |
| Basket removal device | 000000014042230637 | FDA UDI | Class I | Active |
| Lid with slot for load container | 000000014047840337 | FDA UDI | Class I | Active |
| Indicator | 000000014045630906 | FDA UDI | Class I | Active |
| Lid | 000000014042230623 | FDA UDI | Class I | Active |
| ASP6025 100 V/50/60 Hz | 000000014049549361 | FDA UDI | Class I | Active |
| Memory 2-32 GB USB-Memory Stick | 000000014600003467 | FDA UDI | Class I | Active |
| Leica ST5020 Config. 1 | 14905020US1 | FDA UDI | Class I | Active |
| Leica TP1020 with Chloroform | 000000014042242238 | FDA UDI | Class I | Active |
| Leica ASP300 S | 000000014047643515 | FDA UDI | Class I | Active |
| Insert Special Staining | 000000014047534525 | FDA UDI | Class I | Active |
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