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Columbus™ External Reference Patch
EUDAMEDClass I (EU MDR)
Ref EPR105BModel EPTR150ARef EPTR150DRef EPTR150B
Identity
- Trade Name
- Columbus™ External Reference Patch EUDAMED
- Device Name
- Columbus External Reference Patch EUDAMED
- Model / Reference
- EPTR150A EUDAMEDEPR105B EUDAMEDEPTR150D EUDAMEDEPTR150B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06952450982778 EUDAMED06952450982839 EUDAMED06952450982501 EUDAMED
- Basic UDI-DI
- 69524509C6E10G3 EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Columbus™ External Reference Patch by Shanghai Microport Ep Medtech Co., Ltd. — Class I — 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 | 69524509C6E10G3 | Class I | 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 (3)
- EUDAMED 75f47cb6-15ab-44d7-9a31-37ff0d8ef611 61 fields · synced Jul 30, 2026
- EUDAMED cf8274df-c6f8-4501-97cf-3a84cce98c49 61 fields · synced May 17, 2026
- EUDAMED 4a1d5537-a0d3-4f27-8ecb-90fd1baccc6f 61 fields · synced May 17, 2026