Identity
- Trade Name
- HistoStar EUDAMED
- Device Name
- HistoStar Tissue Embedding Center EUDAMED
- Model / Reference
- A81000004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663011471 EUDAMED
- Basic UDI-DI
- 5051663SDL004K8 EUDAMED
- Direct Marketing DI
- 05051663011471 EUDAMED
- EMDN Code
- W0202059004 TISSUE EMBEDDING PROCESSORS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
HistoStar by Shandon Diagnostics Limited — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5051663SDL004K8 | Class A | Active |
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Manufacturer
- Manufacturer
- Shandon Diagnostics Limited
- EUDAMED SRN
- GB-MF-000008187
- Authorised Representative
- Epredia Netherlands B.V. NL-AR-000001488
Sources (1)
- EUDAMED 07552ae4-cdab-4085-9eb6-59966bb5585c 61 fields · synced Jun 19, 2026