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Extracorporeal Blood Tubing Set

by Ningbo Tianyi Medical Appliance Co., Ltd. United States EUDAMED510(k)

Ref TY-NDR-A13, TY-NDR-A37, TY-NDR-A31, TY-NDR-A39, MHC152, TY-NDR-A48, MHC156, TY-NDR-A38, TY-NDR-A25, TY-NDR-A33, TY-NDR-A16, TY-NDR-A23, TY-NDR-A35, TY-NDR-A24, TY-NDR-A15, TY-NDR-A6, TY-NDR-A20, TY-NDR-A7, TY-NDR-A40, TY-NDR-A4, TY-JB-5, TY-NDR-A3, TY-NDR-A1, TY-NDR-A28, TY-NDR-A14, TY-NDR-A43, TY-NDR-A41, TY-NDR-A5, MHC157, MHC150, TY-NDR-A50, TY-NDR-A47, TY-NDR-A29, TY-NDR-A10, TY-NDR-A9, TY-NDR-A2510(k) K251442

Product code FJKEMDN B0280

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number694515573200HV Basic UDI-DIDate11 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251442 Date2 Oct 2025ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · synced 22 Oct 2026

Device Name
Extracorporeal Blood Tubing Set
Model / Reference
TY-NDR-A13, TY-NDR-A37, TY-NDR-A31, TY-NDR-A39, MHC152, TY-NDR-A48, MHC156, TY-NDR-A38, TY-NDR-A25, TY-NDR-A33, TY-NDR-A16, TY-NDR-A23, TY-NDR-A35, TY-NDR-A24, TY-NDR-A15, TY-NDR-A6, TY-NDR-A20, TY-NDR-A7, TY-NDR-A40, TY-NDR-A4, TY-JB-5, TY-NDR-A3, TY-NDR-A1, TY-NDR-A28, TY-NDR-A14, TY-NDR-A43, TY-NDR-A41, TY-NDR-A5, MHC157, MHC150, TY-NDR-A50, TY-NDR-A47, TY-NDR-A29, TY-NDR-A10, TY-NDR-A9, TY-NDR-A2
Primary DI / UDI-DI
06945155743492, 06945155743737, 06945155743676, 06945155743751, 06945155743959, 06945155743843, 06945155743997, 06945155743744, 06945155743614, 06945155743690, 06945155743522, 06945155743591, 06945155743713, 06945155743607, 06945155743515, 06945155743423, 06945155743560, 06945155743430, 06945155743768, 06945155743409, 06945155743911, 06945155743393, 06945155743379, 06945155743645, 06945155743508, 06945155743799, 06945155743775, 06945155743416, 06945155744000, 06945155743935, 06945155743867, 06945155743836, 06945155743652, 06945155743461, 06945155743454, 06945155743386
Basic UDI-DI
694515573200HV
Direct Marketing DI
06945155743492
06945155743737
06945155743676
06945155743751
06945155743959
06945155743843
06945155743997
06945155743744
06945155743614
06945155743690
06945155743522
06945155743591
06945155743713
06945155743607
06945155743515
06945155743423
06945155743560
06945155743430
06945155743768
06945155743409
06945155743911
06945155743393
06945155743379
06945155743645
06945155743508
06945155743799
06945155743775
06945155743416
06945155744000
06945155743935
06945155743867
06945155743836
06945155743652
06945155743461
06945155743454
06945155743386
510(k) Number
FDA Product Code
FJK
EMDN Code
B0280 Blood filters - accessories
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 876.5820
Market of Registration
Poland
Portugal
Belgium
Croatia
Sweden
Slovenia
Norway
Denmark
Northern Ireland
Netherlands
Spain
Hungary
Türkiye
Cyprus
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000029875
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (37)

  • EUDAMED a31c864d-9018-44c0-b50f-daeff2285b21 85 fields · synced 22 Oct 2026
  • EUDAMED 06945155743737|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743676|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743751|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743959|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743843|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743997|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743744|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743614|694515573200HV 61 fields · synced 16 May 2026
  • EUDAMED 06945155743690|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743522|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743591|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743713|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743607|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743515|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743423|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743560|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743430|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743768|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743409|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743911|694515573200HV 61 fields · synced 17 May 2026
  • EUDAMED 06945155743393|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743379|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743645|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743508|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743799|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743775|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743416|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155744000|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743935|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743867|694515573200HV 61 fields · synced 18 May 2026
  • EUDAMED 06945155743836|694515573200HV 61 fields · synced 18 May 2026
  • FDA 510(k) K251442 24 fields · synced 18 May 2026
  • EUDAMED 06945155743652|694515573200HV 61 fields · synced 9 Jul 2026
  • EUDAMED 06945155743461|694515573200HV 61 fields · synced 26 Jul 2026
  • EUDAMED 06945155743454|694515573200HV 61 fields · synced 27 Jul 2026
  • EUDAMED 06945155743386|694515573200HV 61 fields · synced 18 Sep 2026