Identity
- Trade Name
- Cyto-Tek EUDAMEDCyto-Tek® 2500 FDA UDI
- Generic Name
- Cytological centrifuge IVD FDA UDI
- Device Name
- Cyto-Tek 2500 EUDAMEDCytocentrifuge FDA UDI
- Model / Reference
- CF-12E EUDAMED4300 EUDAMEDFDA UDI
- Description
- Cytocentrifuge FDA UDI
Identifiers
- Catalog Number
- 4300 FDA UDI
- Primary DI / UDI-DI
- 04946433600355 EUDAMEDFDA UDI
- Basic UDI-DI
- 49464334300TE EUDAMED
- FDA Product Code
- IFB FDA UDI
- EMDN Code
- W02069004 CYTOCENTRIFUGES 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cyto-Tek by Sakura Seiki Co., Ltd. — 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 | 49464334300TE | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sakura Seiki Co., Ltd.
- EUDAMED SRN
- JP-MF-000022209
- Authorised Representative
- Sakura Finetek Europe B.V. NL-AR-000007853
Sources (2)
- EUDAMED ad9bedb0-9e09-4dcd-8620-f5861093fa3e 61 fields · synced Jul 8, 2026
- FDA UDI d04f548d-6293-4672-ae77-6e7437cf553a 35 fields · synced May 30, 2026