Identity
- Trade Name
- BCL Accessories Kit EUDAMED
- Device Name
- BCL Accessories Kit EUDAMED
- Model / Reference
- 4384101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01240000022421 EUDAMED
- Basic UDI-DI
- 12400000224438410179 EUDAMED
- EMDN Code
- Z12019085 VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- The Kit consists of components that are to be used with the BCL device manufactured by CairnSurgical. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Surgical plume evacuation system tube
BCL Accessories Kit by CairnSurgical Inc — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 12400000224438410179 | Class IIb | Active |
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Manufacturer
- Manufacturer
- CairnSurgical Inc
- EUDAMED SRN
- US-PR-000045238
Sources (1)
- EUDAMED 821b86de-88d1-4f97-83a7-238a3442cc8c 61 fields · synced Jun 18, 2026