Identity
- Trade Name
- DOCUMENT HOLDER KIT EUDAMEDEpredia FDA UDI
- Generic Name
- Tissue embedding unit IVD FDA UDI
- Device Name
- HistoStar Tissue Embedding Center EUDAMEDHistoStar Tissue Embedding System - Accessory FDA UDI
- Model / Reference
- A81010036 EUDAMEDDocument Holder Kit FDA UDI
- Description
- HistoStar Tissue Embedding System - Accessory FDA UDI
Identifiers
- Catalog Number
- A81010036 FDA UDI
- Primary DI / UDI-DI
- 05051663518222 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL004K8 EUDAMED
- Direct Marketing DI
- 05051663518222 EUDAMED
- FDA Product Code
- IDW FDA UDI
- EMDN Code
- W0202059004 TISSUE EMBEDDING PROCESSORS EUDAMED
- GMDN Term
- Tissue embedding unit IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 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
Document Holder Kit 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 | 5051663SDL004K8 | 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 43901173-2bbb-40a0-ab52-13ac6566682e 61 fields · synced Jul 9, 2026
- FDA UDI 472e92b5-0850-45d6-80f5-24a23938eee0 34 fields · synced May 29, 2026