EZ Single and Double Cytofunnel™, White
EUDAMEDFDA UDIClass A (EU MDR)
Identity
- Trade Name
- EZ Single and Double Cytofunnel™, White EUDAMEDEpredia FDA UDI
- Generic Name
- Cytological centrifuge IVD FDA UDI
- Device Name
- Cytospin 4 Cytocentrifuge EUDAMEDCytospin 4 Cytocentrifuge - Accessory FDA UDI
- Model / Reference
- A78710015 EUDAMEDEZ Cytofunnel FDA UDI
- Description
- Cytospin 4 Cytocentrifuge - Accessory FDA UDI
Identifiers
- Catalog Number
- A78710015 FDA UDI
- Primary DI / UDI-DI
- 05051663625302 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL012K7 EUDAMED
- Unit of Use DI
- 05051663000222 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
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
Yes
New Device
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose centrifuge IVD
EZ Single and Double Cytofunnel™, White 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
CE/IVDR
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 adad460f-7e92-449a-a214-cc3825843d7b 61 fields · synced Jul 28, 2026
- FDA UDI ff20d47d-ad88-44aa-85d2-f423155a5fa3 34 fields · synced May 30, 2026