Identity
- Trade Name
- Steradian Shield EUDAMED
- Device Name
- Steradian Shield EUDAMED
- Model / Reference
- SS0200CS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20853714008084 EUDAMED
- Basic UDI-DI
- 0853714008SS0000W5 EUDAMED
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Steradian Shield by Radux Devices, Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0853714008SS0000W5 | Class I | Active |
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Manufacturer
- Manufacturer
- Radux Devices, Inc
- EUDAMED SRN
- US-MF-000034745
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 865fa0ae-db8a-4c95-90e8-ef0e6560090f 61 fields · synced Jul 18, 2026