Identity
- Trade Name
- Cryostar NX50 OPD EUDAMEDEpredia FDA UDI
- Generic Name
- Cryostat microtome IVD FDA UDI
- Device Name
- Cryostar NX50 Cryostat EUDAMED
- Model / Reference
- 957100 EUDAMEDNX50 CRYOSTAR OPD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05051663010146 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL015KD EUDAMED
- Direct Marketing DI
- 05051663010146 EUDAMED
- FDA Product Code
- IDP FDA UDI
- EMDN Code
- W0202059003 CRYOSTAT MICROTOMES EUDAMED
- GMDN Term
- Cryostat microtome 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cryostar NX50 OPD 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 | 5051663SDL015KD | 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 e337cbb3-e496-498d-82dd-3e058f7db603 61 fields · synced Jun 18, 2026
- FDA UDI 266840ec-c1e8-44f8-9ab7-1874029e74a6 32 fields · synced May 30, 2026