Identity
- Trade Name
- ORGANISER 50 SEGMENT EUDAMEDEpredia FDA UDI
- Generic Name
- Tissue processor IVD, automated/semi-automated FDA UDI
- Device Name
- Excelsior AS Tissue Processor EUDAMEDExcelsior AS Tissue Processor - Accessory FDA UDI
- Model / Reference
- A82310038 EUDAMEDOrganiser 50 Segment FDA UDI
- Description
- Excelsior AS Tissue Processor - Accessory FDA UDI
Identifiers
- Catalog Number
- A82310038 FDA UDI
- Primary DI / UDI-DI
- 05051663517553 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL002K4 EUDAMED
- Direct Marketing DI
- 05051663517553 EUDAMED
- FDA Product Code
- IEO FDA UDI
- EMDN Code
- W0202059010 TISSUE PROCESSORS EUDAMED
- GMDN Term
- Tissue processor IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3875 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
Organiser 50 Segment by Shandon Diagnostics Limited — 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 | 5051663SDL002K4 | 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 43f46b5b-4a58-4a3f-8e91-27bfbb7e77cb 61 fields · synced Jun 19, 2026
- FDA UDI 3df895a1-ded0-474c-98d2-59ea0de5b530 34 fields · synced May 30, 2026