Identity
- Trade Name
- SIXTEEN-CS EUDAMED
- Device Name
- X-Ray Detectors EUDAMEDSIXTEEN-CS EUDAMED
- Model / Reference
- 63643851 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290012104879 EUDAMED
- Basic UDI-DI
- 72900121040372 EUDAMEDB-07290012104879 EUDAMED
- Direct Marketing DI
- 07290012104879 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMEDGermany 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
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 8514f9fd-966e-4704-997e-82d10950fb05 61 fields · synced Jun 19, 2026
- EUDAMED 767d10c7-abce-48f7-b1f6-aa7f5ca10e48 61 fields · synced Jun 19, 2026