Identity
- Trade Name
- ASP6025 S 120V/50-60Hz FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use. FDA UDI
- Model / Reference
- 000000014049559068 FDA UDI
- Description
- The ASP6025 S Tissue Processor is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Infiltration with intermedium • Paraffin infiltration of histological tissue specimens. The ASP6025 S can be used as medical IVD product. The improved features of the ASP6025 S are the combination of: • Reduced processing time • Easier reagent exchange • Monitoring the ethanol quality by density measurement as well as the • Ability to replace xylene, a substance that is hazardous (including to the health), with special process protocols. The instrument has been designed so that it is safe to use by the operator as well as for processing specimens. However, the prerequisite for this is that it is operated according to these Instructions for Use. FDA UDI
Identifiers
- Catalog Number
- 14049559068 FDA UDI
- Primary DI / UDI-DI
- 04049188210784 FDA UDI
- FDA Product Code
- IEO FDA UDI
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3875 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Tissue processor IVD, automated/semi-automated
ASP6025 S 120V/50-60Hz by Leica Biosystems Nussloch GmbH — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
Sources (2)
- FDA UDI 1827a447-f4cf-490f-861d-d43f0aaee06d 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 1, 2026