← Back to catalogue
Xeleris 4 DR Processing and Review Workstation
EUDAMEDClass IIa (EU MDR)
Ref 5782764-1
Identity
- Trade Name
- Xeleris 4 DR Processing and Review Workstation EUDAMED
- Device Name
- Xeleris 4 DR Processing & Review Workstation EUDAMED
- Model / Reference
- 5782764-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195278894687 EUDAMED
- Basic UDI-DI
- B-00195278894687 EUDAMED
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Xeleris 4 DR Processing and Review Workstation by GE Hualun Medical Systems Co., Ltd — Class IIa — 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-00195278894687 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GE HUALUN MEDICAL SYSTEMS CO. Ltd
- EUDAMED SRN
- CN-MF-000001189
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (1)
- EUDAMED 7620867d-c8f4-4cac-8c14-a66ae75efffe 61 fields · synced Oct 9, 2026