Identity
- Trade Name
- Arcum EUDAMED
- Device Name
- Pijama de unica folosinta EUDAMED
- Model / Reference
- PIJ042026-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05940780427183 EUDAMED
- Basic UDI-DI
- 5940780427PIJ0420262X EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania 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: Radiation/mechanical corneal shield, reusable
Arcum by Synek Med — 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 | 5940780427PIJ0420262X | Class I | Active |
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Manufacturer
- Manufacturer
- Synek Med
- EUDAMED SRN
- RO-MF-000048751
Sources (1)
- EUDAMED d1b89dbe-1db4-4587-9ec1-42ce572545b8 61 fields · synced Jun 19, 2026