Identity
- Trade Name
- PROTEX EUDAMED
- Device Name
- Lenzuola e lenzuolini monouso tnt EUDAMEDcamici non chirurgici, grembiuli, divise EUDAMEDcuffie e copricapo EUDAMED
- Model / Reference
- 2201 EUDAMEDD/1006 EUDAMEDd/1012 EUDAMED05060/3501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 80543012803802 EUDAMED80543012810060 EUDAMED80543012800696 EUDAMED80543012802676 EUDAMED
- Basic UDI-DI
- 805430128T0306VG EUDAMED805430128t02056M EUDAMED805430128T0207VD EUDAMED
- Direct Marketing DI
- 80543012803802 EUDAMED80543012810060 EUDAMED80543012800696 EUDAMED80543012802676 EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMEDT0207 CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMEDEUDAMED
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: Radiation/mechanical corneal shield, reusable
Protex by 3 M.C. Società per azioni — Class I — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805430128T0306VG | Class I | Active |
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Manufacturer
- Manufacturer
- 3 M.C. Società per azioni
- EUDAMED SRN
- IT-MF-000022649
Sources (4)
- EUDAMED bd8dec7a-5dad-4644-829a-c72b03bd36fe 61 fields · synced Aug 1, 2026
- EUDAMED 472b93f5-6b2a-4d3e-932c-feb0397b3eac 61 fields · synced May 17, 2026
- EUDAMED 66da7c33-5ae6-4ac7-9f82-4aa8e990bd1c 61 fields · synced May 18, 2026
- EUDAMED c6a6f377-3ef1-4829-82ee-2b954aa99f42 61 fields · synced May 19, 2026