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ORO SLEEVE LIGHT CURE LARGE 10.2''x2.2''
EUDAMEDClass I (EU MDR)
Ref RSLLC10.2X2.2
Identity
- Trade Name
- ORO SLEEVE LIGHT CURE LARGE 10.2''x2.2'' EUDAMED
- Device Name
- Sleeves EUDAMED
- Model / Reference
- RSLLC10.2X2.2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061123277646 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
Category: Vascular booties
ORO SLEEVE LIGHT CURE LARGE 10.2''x2.2'' by Reach Global India Pvt. Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Vascular booties.
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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 | 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 e517bce1-288d-49ea-b15d-80455cc8a6ac 61 fields · synced Jun 19, 2026