Identity
- Trade Name
- ORO Indicator Tape Plasma EUDAMED
- Device Name
- Indicator Tapes EUDAMED
- Model / Reference
- RSMPIT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 89061123211824 EUDAMED
- Basic UDI-DI
- 890611232RSMITHK EUDAMED
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
Classification
- Device Class
- Class I 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: Sterilizer/disinfector rack
ORO Indicator Tape Plasma by Reach Global India Pvt. Ltd. — 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 | 890611232RSMITHK | 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 c0472ac6-5b45-4369-b22b-75612cb3cdc0 61 fields · synced Jul 9, 2026