Identity
- Trade Name
- Enterprise Archive version 8 EUDAMEDEnterprise Archive v8 EUDAMED
- Device Name
- Centricity Enterprise Archive/Enterprise Archive EUDAMEDCentricity Enterprise Archive / Enterprise Archive EUDAMED
- Model / Reference
- K2048AED EUDAMED5865732 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278409287 EUDAMED
- Basic UDI-DI
- 8406821BUG00019GZ EUDAMED
- Direct Marketing DI
- 00195278409287 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
Enterprise Archive version 8 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 | 8406821BUG00019GZ | 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 738b9f52-156b-4639-a0f0-b22f86a83038 61 fields · synced Oct 5, 2026
- EUDAMED 88f1df7e-d0ae-4a66-8d55-814db69a99b1 61 fields · synced Oct 5, 2026