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PRIMAX International Primo-W
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref 94 01 000Model Primo-W
Identity
- Trade Name
- PRIMAX International Primo-W EUDAMED
- Device Name
- Primo-W EUDAMED
- Model / Reference
- Primo-W EUDAMED94 01 000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055186671072 EUDAMED
- Basic UDI-DI
- B-08055186671072 EUDAMED
- EMDN Code
- Z11031101 MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Stationary basic diagnostic x-ray system, digital
PRIMAX International Primo-W by A.T.S. Applicazione Tecnologie Speciali s.r.l. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211542 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08055186671072 | Class IIb | Active |
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Manufacturer
- Manufacturer
- A.T.S. Applicazione Tecnologie Speciali s.r.l.
- EUDAMED SRN
- IT-MF-000010734
Sources (2)
- EUDAMED 74822fb9-a9ff-4ee3-b78f-f937669c0128 61 fields · synced Sep 17, 2026
- FDA 510(k) K211542 1 fields · synced May 18, 2026