Identity
- Trade Name
- Cryostar NX50 OVPD EUDAMEDEpredia FDA UDI
- Generic Name
- Cryostat microtome IVD FDA UDI
- Device Name
- Cryostar NX50 Cryostat EUDAMEDCryostar NX50 Cryostat, with low profile blade holder FDA UDI
- Model / Reference
- 957160L EUDAMEDNX50 OVPD, 220-230V FDA UDI
- Description
- Cryostar NX50 Cryostat, with low profile blade holder FDA UDI
Identifiers
- Catalog Number
- 957160L FDA UDI
- Primary DI / UDI-DI
- 05051663003544 EUDAMEDFDA UDI
- Basic UDI-DI
- 5051663SDL015KD EUDAMED
- Direct Marketing DI
- 05051663003544 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 OVPD 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 18599b3c-be6c-4c24-b87a-df4bd5014a7c 61 fields · synced Jul 22, 2026
- FDA UDI 6bf72303-1d38-4528-af46-d5b89cefe45b 34 fields · synced May 30, 2026