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Sansin
EUDAMEDClass IIb (EU MDR)
Ref SM170LModel SM120LB/PC material、SM130LB/PC material、SM140LB/PC material、SM150LB/PC material、SM160LB/PC material、SM170LB/PC material、SM180LB/PC material、SM190LB/PC material、SM200LB/PC material、SM210LB/PC material、SM120LA/PC material、etc.
Identity
- Trade Name
- Sansin EUDAMED
- Device Name
- Hollow Fiber Dialyzers EUDAMED
- Model / Reference
- SM120LB/PC material、SM130LB/PC material、SM140LB/PC material、SM150LB/PC material、SM160LB/PC material、SM170LB/PC material、SM180LB/PC material、SM190LB/PC material、SM200LB/PC material、SM210LB/PC material、SM120LA/PC material、etc. EUDAMEDSM170L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945060580250 EUDAMED
- Basic UDI-DI
- 69450605SX001PG EUDAMED
- EMDN Code
- F01060101,F01060102,F01060103,F01060199 EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Bulgaria EUDAMED
Clinical & Handling
Sterile
Yes
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
Sansin by Jiangxi Sanxin Medtec Co., Ltd. — 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 | 69450605SX001PG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Jiangxi Sanxin Medtec Co., Ltd.
- EUDAMED SRN
- CN-MF-000018456
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 5a6c1cac-e823-4617-b937-004a529fafa3 61 fields · synced May 23, 2026