Identity
- Trade Name
- ORO ISOLATION GOWN NON-STERILE S/M/L/XL/XXL EUDAMED
- Device Name
- ORO ISOLATION GOWN NON STERILE EUDAMED
- Model / Reference
- RIG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061123212050 EUDAMED
- Basic UDI-DI
- 890611232RIGLT EUDAMED
- EMDN Code
- T0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Oro Isolation Gown Non-Sterile S/M/L/Xl/Xxl by Reach Global India Pvt. Ltd. — 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 | 890611232RIGLT | Class I | Active |
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Manufacturer
- Manufacturer
- Reach Global India Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000041886
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 2c4ec25f-38f8-4ac7-8006-57bda6da1412 61 fields · synced Jul 9, 2026