Identity
- Trade Name
- Medis Suite MRCT EUDAMED
- Device Name
- Medis Suite MRCT EUDAMED
- Model / Reference
- 2025 EUDAMED20250203 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B141MEDISSUITEMRCT2025 EUDAMED
- Basic UDI-DI
- B-B141MEDISSUITEMRCT2025 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Medis Suite MRCT by Medis Medical Imaging Systems bv — Class IIa — 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-B141MEDISSUITEMRCT2025 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medis Medical Imaging Systems bv
- EUDAMED SRN
- NL-MF-000002670
Sources (1)
- EUDAMED 27fb75b3-0029-408a-bd17-faa867454051 61 fields · synced May 22, 2026