Identity
- Trade Name
- 2316 SIXTEEN-CS EUDAMED
- Device Name
- X-Ray Detectors EUDAMED2316 SIXTEEN-CS EUDAMED
- Model / Reference
- 63670034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290012104930 EUDAMED
- Basic UDI-DI
- 72900121040372 EUDAMEDB-07290012104930 EUDAMED
- Direct Marketing DI
- 07290012104930 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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: Stationary basic diagnostic x-ray system, digital
2316 Sixteen-Cs by CMT Medical Technologies, Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Stationary basic diagnostic x-ray system, digital.
- EXSYS DEXi — Drtech Corp. · Class II
- DX-D 400 — Agfa Corp. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- CARESTREAM DRX-EVOLUTION — CARESTREAM HEALTH, INC. · Class II
- DRX - Ascend System — CARESTREAM HEALTH, INC. · Class II
- SEDECAL — Sedecal., Sa. · Class II
- Q-RAD System — CARESTREAM HEALTH, INC. · Class II
- iDR603V-110 — YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD. · Class IIb
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 72900121040372 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 72900121040372 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CMT Medical Technologies, Ltd.
- EUDAMED SRN
- IL-MF-000017569
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED df72b612-7fb4-493c-9ee3-d8e3c6a48fff 61 fields · synced Jul 10, 2026
- EUDAMED 238897f6-c96c-4392-bad5-cee0bd6f4513 61 fields · synced Jul 10, 2026