Identity
- Trade Name
- HistoCore SPECTRA CV EUDAMEDFDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- HistoCore SPECTRA CV EUDAMEDThe HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica. FDA UDI
- Model / Reference
- 14051454200 EUDAMED000000014051454200 FDA UDI
- Description
- The HistoCore SPECTRA CV is a fully automated coverslipper that is used to apply mounting media between the slide and coverglass. Then a coverglass is applied in order to preserve conserve the specimen and to create a uniform visual surface for microscopic research on histological and cytological tissue samples for medical diagnostics (e.g. cancer diagnostics). This instrument may be operated only in conjunction with the coverglasses and mounting media approved by Leica. FDA UDI
Identifiers
- Catalog Number
- 14051454200 FDA UDI
- Primary DI / UDI-DI
- 04049188203953 EUDAMEDFDA UDI
- Basic UDI-DI
- 010404918805149L EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059008 AUTOMATED COVERSLIPPERS EUDAMED
- GMDN Term
- Microscope slide coverslip IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 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 SPECTRA CV 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 | 010404918805149L | 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 bb0a2f65-f9fa-47a0-b248-b243ee3f53f0 61 fields · synced Jul 15, 2026
- FDA UDI 6466cf24-8cff-405e-b275-0edae94e3399 37 fields · synced May 30, 2026