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Columbus™ Cardiac Electrophysiology Stimulator
EUDAMEDClass IIb (EU MDR)
Ref DF-5A
Identity
- Trade Name
- Columbus™ Cardiac Electrophysiology Stimulator EUDAMED
- Device Name
- Columbus™ Cardiac Electrophysiology Stimulator EUDAMED
- Model / Reference
- DF-5A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450973547 EUDAMED
- Basic UDI-DI
- B-06952450973547 EUDAMED
- EMDN Code
- Z1205078001 CARDIAC ELECTROPHYSIOLOGY STIMULATORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Columbus™ Cardiac Electrophysiology Stimulator by Shanghai Microport Ep Medtech Co., Ltd. — 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-06952450973547 | Class IIb | 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 9251d011-73ee-4e27-bb28-1b30264f820a 61 fields · synced Jun 18, 2026