Identity
- Trade Name
- Starter Kit, EZ Cytofunnel™ EUDAMEDEpredia FDA UDI
- Generic Name
- Cytological centrifuge IVD FDA UDI
- Device Name
- Cytospin 4 Cytocentrifuge EUDAMEDCytospin 4 Cytocentrifuge - Accessory FDA UDI
- Model / Reference
- A78710013 EUDAMEDCytospin 4 Starter Kit FDA UDI
- Description
- Cytospin 4 Cytocentrifuge - Accessory FDA UDI
Identifiers
- Catalog Number
- A78710013 FDA UDI
- Primary DI / UDI-DI
- 05051663518345 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL012K7 EUDAMED
- Direct Marketing DI
- 05051663518345 EUDAMED
- FDA Product Code
- IFB FDA UDI
- EMDN Code
- W02069003 CENTRIFUGES EUDAMED
- GMDN Term
- Cytological centrifuge IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3300 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose centrifuge IVD
Starter Kit, EZ Cytofunnel™ by Shandon Diagnostics Limited — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 5051663SDL012K7 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
- EUDAMED SRN
- GB-MF-000008187
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (2)
- EUDAMED a815ce5b-0a26-431b-b300-c381b67679e2 61 fields · synced Jul 17, 2026
- FDA UDI ee73d0a3-c8ec-4e01-8cf4-23967619dc42 34 fields · synced May 30, 2026