Identity
- Trade Name
- CustoMED Viewer EUDAMED
- Device Name
- CustoMED Viewer EUDAMED
- Model / Reference
- 07290020565006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290020565006 EUDAMED
- Basic UDI-DI
- 7290020565VIEWER9D EUDAMED
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany 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
Category: Full-body CT system
CustoMED Viewer by CustoMED Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Full-body CT system.
- NAEOTOM Alpha.Prime — Siemens Healthcare · Class II
- SpotLight — Arineta , Ltd. · Class II
- TruPlan — Circle Cardiovascular Imaging Inc · Class IIa
- Osteo mat — Siemens Healthcare · Class II
- TOSHIBA SCANNER — Canon Medical Systems Corporation · Class II
- Bariatric table top — Siemens Healthcare · Class II
- Optima — Hangwei GE Medical Systems Co., Ltd. · Class II
- table extension_P68 — Siemens Shanghai Medical Equipment Ltd. · Class II
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 | 7290020565VIEWER9D | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CustoMED Ltd
- EUDAMED SRN
- IL-MF-000050512
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 0fa52156-9e01-4c61-bdc9-7346440d6327 61 fields · synced Jun 18, 2026