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Rooti
EUDAMEDClass IIa (EU MDR)
Ref RootiCareModel RootiRef RXAP01 Ref RXAP01-50Ref RXAP02, RXAP03, RXMD01, RXMD02, ASCD01
Identity
- Trade Name
- Rooti EUDAMEDRooti Rx EUDAMED
- Device Name
- RootiCare System EUDAMEDRooti Rx System EUDAMED
- Model / Reference
- Rooti EUDAMEDRootiCare EUDAMEDRXAP01 EUDAMEDRXAP01-50 EUDAMEDRXAP02, RXAP03, RXMD01, RXMD02, ASCD01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873370153 EUDAMED04719873370115 EUDAMED04719873370122 EUDAMED04719873370092 EUDAMED
- Basic UDI-DI
- 471987337RootiCare8E EUDAMED471987337RootiRxDJ EUDAMED
- Direct Marketing DI
- 04719873370153 EUDAMED04719873370115 EUDAMED04719873370122 EUDAMED
- EMDN Code
- Z12050892 CARDIAC TELEMETRY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMEDZ12050880 CARDIAC TELEMETRY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMEDZ12050403 ECG HOLTER RECORDERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
EUDAMEDEUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rooti by Rooti Labs Limited. — Class IIa — 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 | 471987337RootiCare8E | Class IIa | Active |
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Manufacturer
- Manufacturer
- Rooti Labs Limited.
- EUDAMED SRN
- TW-MF-000004839
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (5)
- EUDAMED c2d9d22a-f013-472e-bfb3-312437505437 61 fields · synced Jul 19, 2026
- EUDAMED 731e20a9-f1ee-4ed4-b570-7a771f277741 61 fields · synced May 18, 2026
- EUDAMED c79a900c-8429-4e9a-9f03-95aaf5c806dc 61 fields · synced May 18, 2026
- EUDAMED 9d76ffd4-5006-4cf6-9eef-2b21129c538b-1 61 fields · synced Jul 9, 2026
- EUDAMED 9d76ffd4-5006-4cf6-9eef-2b21129c538b-2 61 fields · synced Jul 9, 2026