Identity
- Device Name
- BCL MRI Accessories Kit EUDAMED
- Model / Reference
- 4384103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01240000022414 EUDAMED
- Basic UDI-DI
- 1240000022443841037D EUDAMED
- EMDN Code
- Z11050185 MAGNETIC RESONANCE (MR) SYSTEMS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- This Kit contains components that are to be used during and after MRI Imaging for the BCL System. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
BCL MRI Accessories Kit by CairnSurgical Inc — Class IIa — 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 | 1240000022443841037D | Class IIa | Active |
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Manufacturer
- Manufacturer
- CairnSurgical Inc
- EUDAMED SRN
- US-PR-000045238
Sources (1)
- EUDAMED 2924f681-e078-4dd9-8ca4-8c4b869b0fc2 61 fields · synced Jun 19, 2026