Identity
- Device Name
- Sodium Bicarbonate for Haemodialysis EUDAMED
- Model / Reference
- 304-0650 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62851000809526 EUDAMED
- Basic UDI-DI
- 62851301-0650UK EUDAMED
- EMDN Code
- F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
Classification
- Device Class
- Class IIb 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
Sodium Bicarbonate for Haemodialysis by Saudi Mais Co. For Medical products — Class IIb — 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 | 62851301-0650UK | Class IIb | Active |
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Manufacturer
- Manufacturer
- Saudi Mais Co. For Medical products
- EUDAMED SRN
- SA-MF-000025189
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 80dd4871-f056-4591-961d-07fafa99495d 61 fields · synced Jul 9, 2026