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Centricity RIS-i 7
EUDAMEDClass I (EU MDR)
Ref M82001GPED/M82001GTED/M82001GVED/M82001GZED/M82001HEDRef 5841488
Identity
- Trade Name
- Centricity RIS-i 7 EUDAMEDCentricity RIS-i 7.0.x EUDAMED
- Device Name
- Centricity RIS-i EUDAMED
- Model / Reference
- M82001GPED/M82001GTED/M82001GVED/M82001GZED/M82001HED EUDAMED5841488 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840682147170 EUDAMED
- Basic UDI-DI
- 8406821BUG00009GW EUDAMED
- Direct Marketing DI
- 00840682147170 EUDAMED
- EMDN Code
- Z11030592 RADIOLOGY 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 RIS-i 7 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 | 8406821BUG00009GW | 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 (2)
- EUDAMED 0834d658-430c-4b56-b3a5-8b12610fb429 61 fields · synced Jun 18, 2026
- EUDAMED 7a1bc017-c5fe-456a-9eab-88df91cdea8f 61 fields · synced Jun 18, 2026