Identity
- Trade Name
- SAKURA CARRIER (PK OF 5) EUDAMEDEpredia FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Gemini AS Automatic Stainer EUDAMEDGemini AS Automated Slide Stainer - Accessory FDA UDI
- Model / Reference
- A78010404 EUDAMEDSakura Carrier (PK of 5) FDA UDI
- Description
- Gemini AS Automated Slide Stainer - Accessory FDA UDI
Identifiers
- Catalog Number
- A78010404 FDA UDI
- Primary DI / UDI-DI
- 05051663517218 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL007KE EUDAMED
- Unit of Use DI
- 05051663000055 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 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
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: Microscope slide stainer IVD
Sakura Carrier (pk Of 5) 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 | 5051663SDL007KE | 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 08f5735a-dd83-4d3d-9e5a-986eb39c1f74 61 fields · synced Jun 19, 2026
- FDA UDI f9f528a9-68be-4cc9-9fde-a81854173af8 34 fields · synced May 30, 2026