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Sansin

EUDAMED

Class IIb (EU MDR)

Ref SXG-F-B 02Ref SM200HModel SM120H/PC material 、SM130H/PC material 、SM140H/PC material、 SM150H/PC material、 SM160H/PC material 、SM170H/PC material、 SM180H/PC material 、SM190H/PC material、 SM200H/PC material 、SM210H/PC material 、SM220H/PC material、etc.Ref SM140LModel 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.Ref Type A 1.8mm (15G)Model Type A 1.8mm (15G)、 Type A 1.6mm (16G)、 Type A 1.4mm (17G)、 Type A 1.2mm (18G)、 Type B 1.8mm (15G)、 Type B 1.6mm (16G)、 Type B 1.4mm (17G)、 Type B 1.2mm (18G)etcRef SM210LRef Type A 1.2mm (18G)Ref SM130LRef 30mLAModel HDJ - A0 HDJ - A1 HDJ - A2 HDJ - A3 HDJ - A4 HDJ - A5 HDJ - A6 HDJ - A7 HDJ - A8 HDJ - A9 HDJ - A10 etcRef SM120HRef HDJ - A19Ref SP150HModel SP150H/PP material， SP160H/PP material， SP170H/PP material， SP180H/PP material， SP190H/PP material， SP200H/PP material， SP210H/PP material， SP220H/PP material，etcRef SM160HRef SP220HRef SP170LModel SP15LMA/PP material， SP16LMA/PP material， SP17LMA/PP material， SP18LMA/PP material， SP19LMA/PP material，etcRef SP190LRef SM130HRef SM120LRef SM220HRef SM150HRef SM180LRef SM190HRef SM170HRef HDJ - A22Ref SM150LRef Type B 1.6mm (16G)Ref SP180LRef SP160HRef HDL - A17Ref HDTA - 25Model HDTA - 20 HDTB - 20 HDTC - 20 HDTD - 20 HDTK - 20 HDTL - 20 HDTM - 20 HDTN - 20 HDTO - 20 HDTP - 20 HDTQ - 20 HDTR - 20 HDTS - 20 HDTT - 20 HDTU - 20 HDTV - 20 HDTW - 20 HDTX - 20 HDTY - 20 HDTZ - 20 HDTAA - 20 HDTAB - 20 HDTAC - 20etc.Ref A-V 02Model A-I 01 A-I 02 A-II A-V 01 A-V 02 A-VI etc.Ref HDTB - 20Model HDTA - 20 HDTB - 20 HDTC - 20 HDTD - 20 HDTE - 20 HDTF - 20 HDTG - 20 HDTH - 20 HDTI - 20 HDTJ - 20 HDTK - 20 HDTL - 20 HDTM - 20 HDTN - 20 HDTO - 20 HDTP - 20 HDTQ - 20 HDTR - 20 HDTS - 20 HDTT - 20etc.Model Type A 1.8mm (15G) Type A 1.6mm (16G) Type A 1.4mm (17G) Type A 1.2mm (18G) Type B 1.8mm (15G) Type B 1.6mm (16G) Type B 1.4mm (17G) Type B 1.2mm (18G)Ref SXG-F-A 2335.2gModel type: SXG-F with composition SXG-F-A (weight 1284.5g, 1751.6g, 2335.2g, 5838.6g, 11677.3g) and composition SXG-F-B(Weight 588g, 700g, 1008g, 2520g, 5040g)Ref HDJ - A17Ref Type B 1.8mm (15G)Ref Type A 1.6mm (16G)Ref A-V 01Model HDJ-A0～HDJ-A31、HDJ-B0～HDJ-B31、HDK-A0～HDK-A31、HDK-B0～HDK-B31etcRef SP210HRef HDTB - 30Ref SXG-F-B 5040gModel type: SXG-F with composition SXG-F-A (weight 1284.5g, 1751.6g, 2335.2g, 5838.6g, 11677.3g) and composition SXG-F-B(Weight 588g, 700g, 1008g, 2520g, 5040g)Ref HDJ - B0Ref SP160LRef A-I 02Ref Type B 1.4mm (17G)Ref HDK - A19Ref HDJ - B17Ref HDN - A19Ref HDTA - 20Ref HDL - B20Ref Type B 1.2mm (18G)

by Jiangxi Sanxin Medtec Co., Ltd.

Identity

Trade Name
Sansin EUDAMED
Device Name
Hemodialysis Powders EUDAMED
Hollow Fiber Hemodialysis Dialyzers EUDAMED
Hollow Fiber Dialyzers EUDAMED
A.V. Fistula Needle Sets EUDAMED
Hemodialysis Blood Tubing Sets EUDAMED
Dialysis Fluid Filters EUDAMED
Model / Reference
SXG-F-B 02 EUDAMED
SM120H/PC material 、SM130H/PC material 、SM140H/PC material、 SM150H/PC material、 SM160H/PC material 、SM170H/PC material、 SM180H/PC material 、SM190H/PC material、 SM200H/PC material 、SM210H/PC material 、SM220H/PC material、etc. EUDAMED
SM200H EUDAMED
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. EUDAMED
SM140L EUDAMED
Type A 1.8mm (15G)、 Type A 1.6mm (16G)、 Type A 1.4mm (17G)、 Type A 1.2mm (18G)、 Type B 1.8mm (15G)、 Type B 1.6mm (16G)、 Type B 1.4mm (17G)、 Type B 1.2mm (18G)etc EUDAMED
Type A 1.8mm (15G) EUDAMED
SM210L EUDAMED
Type A 1.2mm (18G) EUDAMED
SM130L EUDAMED
HDJ - A0 HDJ - A1 HDJ - A2 HDJ - A3 HDJ - A4 HDJ - A5 HDJ - A6 HDJ - A7 HDJ - A8 HDJ - A9 HDJ - A10 etc EUDAMED
30mLA EUDAMED
SM120H EUDAMED
HDJ - A19 EUDAMED
SP150H/PP material， SP160H/PP material， SP170H/PP material， SP180H/PP material， SP190H/PP material， SP200H/PP material， SP210H/PP material， SP220H/PP material，etc EUDAMED
SP150H EUDAMED
SM160H EUDAMED
SP220H EUDAMED
SP15LMA/PP material， SP16LMA/PP material， SP17LMA/PP material， SP18LMA/PP material， SP19LMA/PP material，etc EUDAMED
SP170L EUDAMED
SP190L EUDAMED
SM130H EUDAMED
SM120L EUDAMED
SM220H EUDAMED
SM150H EUDAMED
SM180L EUDAMED
SM190H EUDAMED
SM170H EUDAMED
HDJ - A22 EUDAMED
SM150L EUDAMED
Type B 1.6mm (16G) EUDAMED
SP180L EUDAMED
SP160H EUDAMED
HDL - A17 EUDAMED
HDTA - 20 HDTB - 20 HDTC - 20 HDTD - 20 HDTK - 20 HDTL - 20 HDTM - 20 HDTN - 20 HDTO - 20 HDTP - 20 HDTQ - 20 HDTR - 20 HDTS - 20 HDTT - 20 HDTU - 20 HDTV - 20 HDTW - 20 HDTX - 20 HDTY - 20 HDTZ - 20 HDTAA - 20 HDTAB - 20 HDTAC - 20etc. EUDAMED
HDTA - 25 EUDAMED
A-I 01 A-I 02 A-II A-V 01 A-V 02 A-VI etc. EUDAMED
A-V 02 EUDAMED
HDTA - 20 HDTB - 20 HDTC - 20 HDTD - 20 HDTE - 20 HDTF - 20 HDTG - 20 HDTH - 20 HDTI - 20 HDTJ - 20 HDTK - 20 HDTL - 20 HDTM - 20 HDTN - 20 HDTO - 20 HDTP - 20 HDTQ - 20 HDTR - 20 HDTS - 20 HDTT - 20etc. EUDAMED
HDTB - 20 EUDAMED
Type A 1.8mm (15G) Type A 1.6mm (16G) Type A 1.4mm (17G) Type A 1.2mm (18G) Type B 1.8mm (15G) Type B 1.6mm (16G) Type B 1.4mm (17G) Type B 1.2mm (18G) EUDAMED
type: SXG-F with composition SXG-F-A (weight 1284.5g, 1751.6g, 2335.2g, 5838.6g, 11677.3g) and composition SXG-F-B(Weight 588g, 700g, 1008g, 2520g, 5040g) EUDAMED
SXG-F-A 2335.2g EUDAMED
HDJ - A17 EUDAMED
Type B 1.8mm (15G) EUDAMED
Type A 1.6mm (16G) EUDAMED
A-V 01 EUDAMED
HDJ-A0～HDJ-A31、HDJ-B0～HDJ-B31、HDK-A0～HDK-A31、HDK-B0～HDK-B31etc EUDAMED
SP210H EUDAMED
HDTB - 30 EUDAMED
SXG-F-B 5040g EUDAMED
HDJ - B0 EUDAMED
SP160L EUDAMED
A-I 02 EUDAMED
Type B 1.4mm (17G) EUDAMED
HDK - A19 EUDAMED
HDJ - B17 EUDAMED
HDN - A19 EUDAMED
HDTA - 20 EUDAMED
HDL - B20 EUDAMED
Type B 1.2mm (18G) EUDAMED

Identifiers

Primary DI / UDI-DI
06945060593939 EUDAMED
06945060580595 EUDAMED
06945060580229 EUDAMED
06945060591881 EUDAMED
06945060580298 EUDAMED
06945060591911 EUDAMED
06945060580212 EUDAMED
06945060585200 EUDAMED
06945060580519 EUDAMED
06945060582070 EUDAMED
06945060581806 EUDAMED
06945060580557 EUDAMED
06945060581875 EUDAMED
06945060580458 EUDAMED
06945060580472 EUDAMED
06945060580526 EUDAMED
06945060580205 EUDAMED
06945060580618 EUDAMED
06945060580540 EUDAMED
06945060580267 EUDAMED
06945060580588 EUDAMED
06945060580564 EUDAMED
06945060582100 EUDAMED
06945060580236 EUDAMED
06945060591935 EUDAMED
06945060580465 EUDAMED
06945060581813 EUDAMED
06945060583336 EUDAMED
06945060588904 EUDAMED
06945060592161 EUDAMED
06945060590242 EUDAMED
06945060592017 EUDAMED
16945060593936 EUDAMED
06945060582056 EUDAMED
06945060592000 EUDAMED
06945060591973 EUDAMED
06945060592154 EUDAMED
06945060585408 EUDAMED
06945060581868 EUDAMED
06945060590884 EUDAMED
86945060593935 EUDAMED
06945060582209 EUDAMED
06945060580441 EUDAMED
06945060591966 EUDAMED
06945060592130 EUDAMED
06945060592024 EUDAMED
06945060582711 EUDAMED
06945060585729 EUDAMED
06945060584630 EUDAMED
06945060588584 EUDAMED
06945060583688 EUDAMED
06945060592031 EUDAMED
Basic UDI-DI
B-06945060593939 EUDAMED
69450605SX003PL EUDAMED
69450605SX001PG EUDAMED
69450605SX009PY EUDAMED
69450605SX005PQ EUDAMED
69450605SX004PN EUDAMED
69450605SX002PJ EUDAMED
69450605SX007PU EUDAMED
69450605SX055Q7 EUDAMED
69450605SX008PW EUDAMED
69450605SX010PH EUDAMED
B-16945060593936 EUDAMED
69450605SX006PS EUDAMED
B-86945060593935 EUDAMED
EMDN Code
F040201 DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER EUDAMED
F01060301,F01060302,F01060303,F01060399 EUDAMED
F01060101,F01060102,F01060103,F01060199 EUDAMED
A010401 ARTERIOVENOUS FISTULA NEEDLES EUDAMED
F020102 ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES EUDAMED
F01080201 ENDOTOXIN REMOVAL FILTERS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class IIa EUDAMED
Market of Registration
Bulgaria EUDAMED

Clinical & Handling

Sterile

No

EUDAMEDEUDAMED

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 — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

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 (52)

  • EUDAMED 74576afd-40e7-4719-b126-0bc053b4751a 61 fields · synced Sep 18, 2026
  • EUDAMED 146f2683-4fa0-41f3-b655-5f734241f523 61 fields · synced May 11, 2026
  • EUDAMED a1bdf713-d454-427f-9b80-c64049e897c4 61 fields · synced May 16, 2026
  • EUDAMED 3619d7a5-f21e-4940-82a4-ed75d79f9bae 61 fields · synced May 16, 2026
  • EUDAMED f3766ba5-3d7f-4c98-aa99-8ee737e55311 61 fields · synced May 16, 2026
  • EUDAMED 773d014c-fd88-488c-a754-fe4456c694f6 61 fields · synced May 16, 2026
  • EUDAMED a0565064-7e43-4f43-80b7-7428695e9cd1 61 fields · synced May 16, 2026
  • EUDAMED 9989a1f8-7025-444a-89d3-aaf044cfd47c 61 fields · synced May 16, 2026
  • EUDAMED 5f5a926d-e0cc-44e3-91e4-5b928ae3a24e 61 fields · synced May 16, 2026
  • EUDAMED 9fa50144-687b-4ccb-a73b-664c03b35c65 61 fields · synced May 17, 2026
  • EUDAMED 80b1e5be-54e9-42fc-9bb4-80ad4748cfa3 61 fields · synced May 17, 2026
  • EUDAMED a45cfafa-fd94-4742-8384-88decdd8ebbc 61 fields · synced May 17, 2026
  • EUDAMED 3c9de64f-0eb3-48c3-abe2-fe4f0994cef6 61 fields · synced May 17, 2026
  • EUDAMED 7a97be91-9f54-4376-928e-1467ba509ae4 61 fields · synced May 17, 2026
  • EUDAMED f47d1ec4-414b-416a-983e-ce96b24a41b6 61 fields · synced May 17, 2026
  • EUDAMED b5f46a01-2134-4939-9ec5-6b9e31e8812c 61 fields · synced May 17, 2026
  • EUDAMED ce9bb0b8-ce33-43cb-8acf-8d0f96268ce6 61 fields · synced May 17, 2026
  • EUDAMED cf9a9bb4-6c63-43d0-8310-da04fd3610ed 61 fields · synced May 17, 2026
  • EUDAMED 211e5ea4-edeb-423e-a469-d6808b2bac3f 61 fields · synced May 18, 2026
  • EUDAMED 6b6f421b-d2f7-4a79-966c-4d76d7e931e2 61 fields · synced May 18, 2026
  • EUDAMED ce2d686b-4ede-4be0-879e-852b6127326b 61 fields · synced May 18, 2026
  • EUDAMED 6163ec35-7350-491a-a023-7793418e0343 61 fields · synced May 18, 2026
  • EUDAMED 29701f40-ce75-4957-846b-ee970d422813 61 fields · synced May 18, 2026
  • EUDAMED b714f3bf-ce59-4ea4-ad0b-153a19f4c598 61 fields · synced May 18, 2026
  • EUDAMED 4629e1eb-9547-47ed-9b40-d043f5a943fa 61 fields · synced May 18, 2026
  • EUDAMED 3fd02c3c-3357-4c20-b264-0f40c7d281ae 61 fields · synced May 18, 2026
  • EUDAMED fd1ecb59-d6d0-4a81-93ca-dd3b851d9978 61 fields · synced May 18, 2026
  • EUDAMED 4d5b2ff3-725d-4fc7-be25-d2b8193aad70 61 fields · synced Jul 9, 2026
  • EUDAMED c46dd5c6-d2fc-48db-a98c-62af61034040 61 fields · synced Jul 9, 2026
  • EUDAMED 0d5f057d-ee13-4877-a36b-30ed300c1860 61 fields · synced Jul 9, 2026
  • EUDAMED 7f391697-202f-45d3-a1af-3e4ad3029951 61 fields · synced Jul 10, 2026
  • EUDAMED 6a775877-aaf5-4493-858f-c93298f29fce 61 fields · synced Jul 10, 2026
  • EUDAMED 0ee2f5f5-61ce-4f2d-9ae8-794f4226d424 61 fields · synced Jul 12, 2026
  • EUDAMED 694e15d2-c12b-454f-a5c0-4be419c68e74 61 fields · synced Jul 13, 2026
  • EUDAMED 0f149c9d-5397-4a00-8f95-256cf8bdaf40 61 fields · synced Jul 13, 2026
  • EUDAMED 12f6588e-fc86-4bd6-b8a7-4e611cff8bde 61 fields · synced Jul 14, 2026
  • EUDAMED 3a9b1398-a5d7-4dfe-ac67-3cc0f37b6ba4 61 fields · synced Jul 16, 2026
  • EUDAMED 6995c425-5a02-4e6b-b01c-4f5984af6371 61 fields · synced Jul 17, 2026
  • EUDAMED b0467a4f-26e7-44f2-bc88-6dc45f165cad 61 fields · synced Jul 18, 2026
  • EUDAMED e077738e-3d3e-46a3-9643-0f6de6188533 61 fields · synced Jul 20, 2026
  • EUDAMED 767085aa-750b-4d4c-b206-916564acfacb 61 fields · synced Jul 20, 2026
  • EUDAMED d2d67f1e-edbb-40a8-ba6c-6329001d5eba 61 fields · synced Jul 21, 2026
  • EUDAMED 9364f9c9-6f79-4e77-95bb-5dcc907f18c0 61 fields · synced Jul 22, 2026
  • EUDAMED 16835848-a35d-48de-be2f-1cb06b36940f 61 fields · synced Jul 23, 2026
  • EUDAMED 2fa5f29e-08d1-45fa-bb2d-7f8ba43e6c0c 61 fields · synced Jul 23, 2026
  • EUDAMED 23ea2518-2e1f-484e-b3a6-840a2d7e5f4c 61 fields · synced Jul 26, 2026
  • EUDAMED 8a423569-b953-48f7-be00-43b92104cdc9 61 fields · synced Jul 26, 2026
  • EUDAMED a6c36299-56d7-414a-ace9-7c361ed20c79 61 fields · synced Jul 30, 2026
  • EUDAMED 9b9a725d-012d-4682-adb7-9654135f188b 61 fields · synced Aug 1, 2026
  • EUDAMED f5926342-f267-4096-af1f-b736adfa8e32 61 fields · synced Aug 1, 2026
  • EUDAMED f87fcfbd-fb99-4a45-a809-8b9c9a943071 61 fields · synced Aug 3, 2026
  • EUDAMED e3848b99-55f1-4b4b-b4b6-bcc91e60b83d 61 fields · synced Sep 18, 2026