Eu Mdd
Eu Md Class 2b
No Longer On The Market
🇮🇳 India
Renalyx Extending Renal Care
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-IN-MF-00003152921GG
- Basic UDI-DI Code
- B-IN-MF-00003152921GG
- Reference
- RxT21 UM-001
- Device Types
-
Reprocessed
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- No Longer On The Market
- Manufacturer
- Renalyx Health Systems Pvt Ltd
Additional Description
RxT21 is designed to perform hemodialysis in hospitals and dialysis clinics on patients suffering from chronic renal failure. Parameters such as UF, conductivity, heparin, dialysate flow and temperature are displayed. Treatment is performed with concentrate solution (acid and bicarbonate) supplied from separate canisters or from central supply
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12090201 | HAEMODIALYSIS EQUIPMENT |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 105265 0001 | TÜV SÜD Product Service GmbH | Expired |
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