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Centricity Cardio Workflow v7.0
EUDAMEDClass I (EU MDR)
Ref P00051BHED(BJED),P0005FAED(FED/FFED/LCED/SHED/SJED/SLED/SMED),P0007BCED,P1005JAED,P1000JKEDRef 5838392
Identity
- Trade Name
- Centricity Cardio Workflow v7.0 EUDAMED
- Device Name
- Centricity Cardio Workflow EUDAMED
- Model / Reference
- P00051BHED(BJED),P0005FAED(FED/FFED/LCED/SHED/SJED/SLED/SMED),P0007BCED,P1005JAED,P1000JKED EUDAMED5838392 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682147200 EUDAMED
- Basic UDI-DI
- 8406821BUG00002GG EUDAMED
- Direct Marketing DI
- 00840682147200 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
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
Centricity Cardio Workflow v7.0 by GE Healthcare — 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 | 8406821BUG00002GG | Class I | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
- EUDAMED SRN
- US-MF-000001862
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 7175fdc6-b889-418e-8822-d0246ce12907 61 fields · synced Jun 19, 2026
- EUDAMED 7175fdc6-b889-418e-8822-d0246ce12907-1 61 fields · synced Jun 9, 2026
- EUDAMED b7070d8d-db33-4717-99a5-fb0d2bcab963 61 fields · synced Jun 14, 2026