Identity
- Trade Name
- HistoCore PEARL EUDAMEDFDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- HistoCore PEARL EUDAMEDThe HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in sequential mode, which means that the instrument is strictly using one bottle after the other. The HistoCore PEARL is a tissue processor for the following laboratory applications: Fixation Dehydration Infiltration with intermedium Paraffin infiltration of histological tissue specimens. The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible reagents FDA UDI
- Model / Reference
- 14049350667 EUDAMED000000014049350667 FDA UDI
- Description
- The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in sequential mode, which means that the instrument is strictly using one bottle after the other. The HistoCore PEARL is a tissue processor for the following laboratory applications: Fixation Dehydration Infiltration with intermedium Paraffin infiltration of histological tissue specimens. The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible reagents FDA UDI
Identifiers
- Catalog Number
- 14049350667 FDA UDI
- Primary DI / UDI-DI
- 04049188198907 EUDAMEDFDA UDI
- Basic UDI-DI
- 01040491880493A5 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
HistoCore PEARL 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 | 01040491880493A5 | 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 57caafb0-a85d-4664-942c-de99c1f2a0f9 61 fields · synced Jul 9, 2026
- FDA UDI 9e5b6114-3709-496a-a0b1-ead483e048a5 37 fields · synced May 30, 2026