Identity
- Trade Name
- SIXTEEN-GP EUDAMED
- Device Name
- X-Ray Detectors EUDAMEDSIXTEEN-GP EUDAMED
- Model / Reference
- 63658219 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290012104893 EUDAMED
- Basic UDI-DI
- 72900121040372 EUDAMEDB-07290012104893 EUDAMED
- Direct Marketing DI
- 07290012104893 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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-Gp by CMT Medical Technologies, Ltd. — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- CMT Medical Technologies, Ltd.
- EUDAMED SRN
- IL-MF-000017569
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED eb597959-213b-47b8-bbe6-1ee5bd16aab8 61 fields · synced Jul 18, 2026
- EUDAMED 0fa47036-bdb0-4bd0-8435-893ef48c652a 61 fields · synced Jul 18, 2026