Identity
- Trade Name
- Columbus™ Reference Patch EUDAMED
- Device Name
- Columbus™ Reference Patch EUDAMED
- Model / Reference
- EPR 105 A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450953693 EUDAMED
- Basic UDI-DI
- B-06952450953693 EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Columbus™ Reference Patch by Shanghai Microport Ep Medtech Co., Ltd. — 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-06952450953693 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shanghai MicroPort EP MedTech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008518
- Authorised Representative
- MicroPort Medical B.V. NL-AR-000000166
Sources (1)
- EUDAMED 788a54b9-dc12-41dd-9c2e-f3ab5c923f13 61 fields · synced Jun 18, 2026