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Italray Carmex Rk Fp
EUDAMEDClass IIb (EU MDR)
Ref 74 10 000-2 / 74 12 000-2Model CARMEX RK FPRef 74 10 000-2; 74 12 000-2Model ARCO FP
Identity
- Trade Name
- ITALRAY CARMEX RK FP EUDAMEDCARMEX RK FP EUDAMED
- Device Name
- CARMEX RK FP EUDAMED
- Model / Reference
- CARMEX RK FP EUDAMED74 10 000-2 / 74 12 000-2 EUDAMEDARCO FP EUDAMED74 10 000-2; 74 12 000-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186670938 EUDAMED
- Basic UDI-DI
- B-08055186670938 EUDAMED805518667FPVP EUDAMED
- Direct Marketing DI
- 08055186670938 EUDAMED
- EMDN Code
- Z11039017 MOBILE RADIOSCOPIC UNITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy 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
Italray Carmex Rk Fp by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08055186670938 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186670938 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (3)
- EUDAMED 3b70795e-eeac-4bab-bc23-621cfc5739d3 61 fields · synced Oct 6, 2026
- EUDAMED 59b61da8-4d40-4a3d-b2ad-93c19a9c80f6 61 fields · synced May 18, 2026
- EUDAMED 59b61da8-4d40-4a3d-b2ad-93c19a9c80f6-1 61 fields · synced Jun 10, 2026