Identity
- Trade Name
- Leica ASP300 S EUDAMEDLeica ASP300 S - 230-240V FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- Leica ASP300 S EUDAMEDThe instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. FDA UDI
- Model / Reference
- 14047643514 EUDAMED000000014047643514 FDA UDI
- Description
- The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens. FDA UDI
Identifiers
- Catalog Number
- 14047643514 FDA UDI
- Primary DI / UDI-DI
- 04049188055972 EUDAMEDFDA UDI
- Basic UDI-DI
- 01040491880476A5 EUDAMED
- FDA Product Code
- IEO FDA UDI
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3875 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Leica ASP300 S by Leica Biosystems Nussloch Gmbh — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 01040491880476A5 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (2)
- EUDAMED 65c31a5a-6333-435b-b094-46e56dd1f724 61 fields · synced Jul 18, 2026
- FDA UDI 0162a154-f7ed-431a-9112-0f2e569af440 37 fields · synced May 29, 2026