Identity
- Trade Name
- Leica CV5030 EUDAMEDFDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- Leica CV5030 EUDAMEDThe 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 different cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH. FDA UDI
- Model / Reference
- 14047839700 EUDAMED000000014047839700 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 different cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH. FDA UDI
Identifiers
- Catalog Number
- 14047839700 FDA UDI
- Primary DI / UDI-DI
- 04049188051035 EUDAMEDFDA UDI
- Basic UDI-DI
- 01040491880478A9 EUDAMED
- FDA Product Code
- KIM 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
- 864.3400 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 CV5030 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 | 01040491880478A9 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Leica Biosystems Nussloch GmbH
- EUDAMED SRN
- DE-MF-000021943
Sources (2)
- EUDAMED 7a11eb3a-2a0d-48c4-b45b-821295945aae 61 fields · synced Jun 1, 2026
- FDA UDI 8babb934-7241-4d92-a16b-6fa501689384 37 fields · synced May 29, 2026