Identity
- Trade Name
- Cryostar NX50 OP HC EUDAMED
- Device Name
- Cryostar NX50 Cryostat EUDAMED
- Model / Reference
- 957220 EUDAMED957220L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663011587 EUDAMED05051663011709 EUDAMED
- Basic UDI-DI
- 5051663SDL015KD EUDAMED
- Direct Marketing DI
- 05051663011587 EUDAMED05051663011709 EUDAMED
- EMDN Code
- W0202059003 CRYOSTAT MICROTOMES 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
Cryostar NX50 OP HC 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 | 5051663SDL015KD | 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 (2)
- EUDAMED a57bb7ae-7904-48ba-97f1-cbca1e19966b 61 fields · synced Jul 17, 2026
- EUDAMED f27b4662-a31f-47fa-a974-64934551ee73 61 fields · synced May 17, 2026