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TruSkan S500
EUDAMEDClass IIb (EU MDR)
Ref F3-86-390-1006-03 Model TruSkan S500
Identity
- Trade Name
- TruSkan S500 EUDAMED
- Model / Reference
- TruSkan S500 EUDAMEDF3-86-390-1006-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904269454484 EUDAMED
- Basic UDI-DI
- B-18904269454484 EUDAMED
- EMDN Code
- Z1203020201 MULTI–PARAMETER PATIENT BEDSIDE MONITORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TruSkan S500 by Skanray Technologies Limited — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-18904269454484 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Skanray Technologies Limited
- EUDAMED SRN
- IN-MF-000034819
- Authorised Representative
- SKANRAY EUROPE SRL IT-AR-000013034
Sources (1)
- EUDAMED 7c661dd2-ca9f-41aa-b3cc-1a0831bf988f 61 fields · synced Jun 19, 2026