Identity
- Trade Name
- Rooti Rx EUDAMED
- Device Name
- Rooti Rx Patch T EUDAMED
- Model / Reference
- Rooti Rx Patch EUDAMEDRXAP02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873370139 EUDAMED
- Basic UDI-DI
- 471987337RootiRxPatchTH8 EUDAMED
- Direct Marketing DI
- 04719873370139 EUDAMED
- EMDN Code
- Z12050880 CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES 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
Rooti Rx by Rooti Labs Limited. — 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 | 471987337RootiRxPatchTH8 | Class I | Active |
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Manufacturer
- Manufacturer
- Rooti Labs Limited.
- EUDAMED SRN
- TW-MF-000004839
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED bc55753c-86e4-4e5d-bae5-89ee2d242788 61 fields · synced May 23, 2026