Identity
- Trade Name
- Leica CV5030-TS5025 FDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of differ¬ent cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH. FDA UDI
- Model / Reference
- 149CVTS5025 FDA UDI
- Description
- The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of differ¬ent cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH. FDA UDI
Identifiers
- Catalog Number
- 149CVTS5025 FDA UDI
- Primary DI / UDI-DI
- 04049188001887 FDA UDI
- FDA Product Code
- KIM FDA UDI
- GMDN Term
- Microscope slide coverslip IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3400 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: Microscope slide coverslip IVD
Leica CV5030-TS5025 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 282f9676-1261-4b84-8683-a40cb5e517f7 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026