Identity
- Trade Name
- Sansin EUDAMED
- Device Name
- Hemodialysis Powders EUDAMED
- Model / Reference
- SXG-F-B 02 EUDAMEDSXG-F-B 02 700g EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56945060593934 EUDAMED
- Basic UDI-DI
- B-56945060593934 EUDAMED
- EMDN Code
- F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sansin by Jiangxi Sanxin Medtec Co., 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-56945060593934 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jiangxi Sanxin Medtec Co., Ltd.
- EUDAMED SRN
- CN-MF-000018456
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 345ffb20-5005-4711-a596-0710f44b01b0 61 fields · synced May 23, 2026