Identity
- Trade Name
- SMARTSIGNS EUDAMED
- Device Name
- SC300 SPOT MONITOR EUDAMED
- Model / Reference
- SC300 EUDAMEDSC1500 12N EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05051968040831 EUDAMED
- Basic UDI-DI
- 5060693520372WF EUDAMED
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Smartsigns by Arjohuntleigh AB — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5060693520372WF | Class IIb | Active |
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Manufacturer
- Manufacturer
- ArjoHuntleigh AB
- EUDAMED SRN
- SE-MF-000000696
Sources (1)
- EUDAMED 4df28f5c-1226-4820-ad57-a0611ecdd0cb 61 fields · synced Jun 18, 2026