Identity
- Trade Name
- ORO SLEEVE OPG BITE BLOCK 2.7”X1.1” EUDAMED
- Device Name
- Sleeves EUDAMED
- Model / Reference
- RSLOBB2.7X1.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061123277578 EUDAMED
- Basic UDI-DI
- 890611232RSLN3 EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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 Sleeve Opg Bite Block 2.7”x1.1” 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 | 890611232RSLN3 | 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 7c16c7f8-fca4-40e1-9319-26449adcf474 61 fields · synced Jul 28, 2026