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Renalyx Extending Renal Care
EUDAMEDClass IIb (EU MDR)
Ref RxT21 UM-001Model RxT21
Identity
- Trade Name
- Renalyx Extending Renal Care EUDAMED
- Device Name
- Hemodialysis Equipment EUDAMED
- Model / Reference
- RxT21 EUDAMEDRxT21 UM-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-IN-MF-00003152921GG EUDAMED
- Basic UDI-DI
- B-IN-MF-00003152921GG EUDAMED
- EMDN Code
- Z12090201 HAEMODIALYSIS EQUIPMENT EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Renalyx Extending Renal Care by Renalyx Health Systems Pvt Ltd — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-IN-MF-00003152921GG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Renalyx Health Systems Pvt Ltd
- EUDAMED SRN
- IN-MF-000031529
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED 542b4b95-b192-437a-9f55-99416b466bbc 61 fields · synced Jun 19, 2026