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Hm525 Nx Hc Uv
EUDAMEDClass A (EU MDR)
Ref 956651Ref 956650EC70Ref 956650Ref 956651EC70
Identity
- Trade Name
- HM525 NX HC UV EUDAMEDHM525 NX HC EUDAMED
- Device Name
- HM525 NX Cryostat EUDAMED
- Model / Reference
- 956651 EUDAMED956650EC70 EUDAMED956650 EUDAMED956651EC70 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051663011464 EUDAMED05051663011433 EUDAMED05051663011457 EUDAMED05051663011440 EUDAMED
- Basic UDI-DI
- 5051663SDL014KB EUDAMED
- Direct Marketing DI
- 05051663011464 EUDAMED05051663011433 EUDAMED05051663011457 EUDAMED05051663011440 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
Hm525 Nx Hc Uv 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 | 5051663SDL014KB | 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 (4)
- EUDAMED 134fcf5d-15fd-434d-92d1-6d4817c946f9 61 fields · synced Jul 16, 2026
- EUDAMED d1810eb1-4f77-4a59-95b3-21cf7b74d939 61 fields · synced May 17, 2026
- EUDAMED 428d23bb-dce8-4522-a377-8af89dec776a 61 fields · synced May 19, 2026
- EUDAMED 7661b6e4-819a-4ffa-9d35-dbe7646ea28d 61 fields · synced May 19, 2026