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Insulin pen needle

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref NoModel Type I, Type IB, Type VIModel Type V, Type XModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX

by Tianjin Huahong Technology Co., Ltd.

Identity

Device Name
Insulin pen needle EUDAMED
Pen Needle EUDAMED
Model / Reference
Type I, Type IB, Type VI EUDAMED
No EUDAMED
Type V, Type X EUDAMED
Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX EUDAMED

Identifiers

Primary DI / UDI-DI
06957138616150 EUDAMED
06957138616815 EUDAMED
06957138613845 EUDAMED
06957138613777 EUDAMED
06957138612985 EUDAMED
06957138609701 EUDAMED
06957138611438 EUDAMED
06957138606090 EUDAMED
06957138613760 EUDAMED
06957138616068 EUDAMED
06957138616839 EUDAMED
06957138613708 EUDAMED
06957138612039 EUDAMED
06957138616006 EUDAMED
06957138608278 EUDAMED
06957138612169 EUDAMED
06957138612602 EUDAMED
06957138609787 EUDAMED
06957138611278 EUDAMED
06957138616075 EUDAMED
06957138613746 EUDAMED
06957138612701 EUDAMED
06957138616136 EUDAMED
06957138616143 EUDAMED
06957138609633 EUDAMED
06957138605918 EUDAMED
06957138613807 EUDAMED
06957138616846 EUDAMED
06957138611292 EUDAMED
06957138609688 EUDAMED
06957138608292 EUDAMED
06957138610646 EUDAMED
06957138609138 EUDAMED
06957138616051 EUDAMED
06957138607363 EUDAMED
06957138608285 EUDAMED
06957138616013 EUDAMED
06957138616853 EUDAMED
06957138609695 EUDAMED
06957138610851 EUDAMED
06957138613715 EUDAMED
06957138611285 EUDAMED
06957138609725 EUDAMED
06957138609718 EUDAMED
Basic UDI-DI
69571386PN03WK EUDAMED
69571386PD07V9 EUDAMED
69571386PN10WG EUDAMED
69571386PN04WM EUDAMED
69571386PD08VB EUDAMED
Unit of Use DI
56957138616155 EUDAMED
56957138616810 EUDAMED
56957138613840 EUDAMED
56957138613772 EUDAMED
56957138612980 EUDAMED
56957138609706 EUDAMED
56957138611433 EUDAMED
56957138606095 EUDAMED
56957138613765 EUDAMED
56957138616063 EUDAMED
56957138616834 EUDAMED
56957138613703 EUDAMED
56957138612034 EUDAMED
56957138616001 EUDAMED
56957138608273 EUDAMED
56957138612164 EUDAMED
56957138612607 EUDAMED
56957138609782 EUDAMED
56957138611273 EUDAMED
56957138616070 EUDAMED
56957138613741 EUDAMED
56957138612706 EUDAMED
56957138616131 EUDAMED
56957138616148 EUDAMED
56957138609638 EUDAMED
56957138605913 EUDAMED
56957138613802 EUDAMED
56957138616841 EUDAMED
56957138611297 EUDAMED
56957138609683 EUDAMED
56957138608297 EUDAMED
56957138610641 EUDAMED
56957138616056 EUDAMED
56957138607368 EUDAMED
56957138608280 EUDAMED
56957138616018 EUDAMED
56957138616858 EUDAMED
56957138609690 EUDAMED
56957138610856 EUDAMED
56957138613710 EUDAMED
56957138611280 EUDAMED
56957138609720 EUDAMED
56957138609713 EUDAMED
EMDN Code
A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Italy EUDAMED
Spain EUDAMED
Germany 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

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Insulin pen needle by Tianjin Huahong Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Tianjin Huahong Technology Co., Ltd.
EUDAMED SRN
CN-MF-000015849
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (46)

  • EUDAMED 664b2381-d15d-488f-aa7c-cbf87b14d85c 61 fields · synced Sep 18, 2026
  • EUDAMED 93a31bc0-b801-4d42-ad98-eebaf06171c9 61 fields · synced May 11, 2026
  • EUDAMED 1a0ba2d1-dad0-4b70-bc86-4ca3639a1f4d 61 fields · synced May 11, 2026
  • EUDAMED 190cd1f4-6428-4aff-8ee0-96a49c4e3874 61 fields · synced May 11, 2026
  • EUDAMED 27eb413a-d920-468e-8a1d-c347fbfc9266 61 fields · synced May 16, 2026
  • EUDAMED c9ecdace-3c05-44ce-8711-1b659aefb4cc 61 fields · synced May 16, 2026
  • EUDAMED b64bf32d-8c98-44e4-9e67-bb81743dc9f9 61 fields · synced May 17, 2026
  • EUDAMED 355b6a5b-a05f-4e5a-85f0-4ae45b425a66 61 fields · synced May 17, 2026
  • EUDAMED 0120647b-51eb-4854-870d-b46f69cd471f 61 fields · synced May 17, 2026
  • EUDAMED f909e2dc-9793-43a3-9c4d-5650326eeda8 61 fields · synced May 17, 2026
  • EUDAMED 3be8d895-ff46-420e-a37f-3fe1031c47ed 61 fields · synced May 17, 2026
  • EUDAMED 55540284-37cf-457f-bb4b-309efb69d167 61 fields · synced May 17, 2026
  • EUDAMED cb5f0522-236b-47cf-aaab-00860ff0e8b8 61 fields · synced May 17, 2026
  • EUDAMED 9e450428-e9c5-439e-b9d7-b4f0acdb6b6e 61 fields · synced May 17, 2026
  • EUDAMED 283a4e6a-d041-4c43-bd68-8df37d7a48fe 61 fields · synced May 17, 2026
  • EUDAMED 649a5210-5ca7-4ad1-bfb2-7b15ee802ff3 61 fields · synced May 17, 2026
  • EUDAMED d7fe7498-a7de-444a-90c5-623db5ce3d2f 61 fields · synced May 17, 2026
  • EUDAMED 7f999440-0ab3-497a-8831-e6e7a4b48f4e 61 fields · synced May 17, 2026
  • EUDAMED 4943e64a-5b34-4ad1-a79f-fa80bfaa9b0a 61 fields · synced May 17, 2026
  • EUDAMED 135b45be-1765-416f-999b-3c3c9e34512f 61 fields · synced May 17, 2026
  • EUDAMED 465cfdf5-bc77-4860-b058-c7afd093b846 61 fields · synced May 17, 2026
  • EUDAMED 113030ed-a08a-43d6-8e42-4ba58bce1f3a 61 fields · synced May 18, 2026
  • EUDAMED ecef8a07-d1b0-4a52-83ae-caae5ece71cc 61 fields · synced May 18, 2026
  • EUDAMED c99471d2-3526-45ce-be48-19c1af932856 61 fields · synced Jun 20, 2026
  • EUDAMED acd94581-e4b2-4a23-a0a6-b36a579bb15d 61 fields · synced Jun 20, 2026
  • EUDAMED 7999cc06-d0c0-49fc-a379-d65c4c5c0b53 61 fields · synced Jul 8, 2026
  • EUDAMED 39f25eca-31b2-4467-a937-284c4901fa34 61 fields · synced Jul 8, 2026
  • EUDAMED 4b95f662-d506-40af-a4f9-137c4d8e6528 61 fields · synced Jul 10, 2026
  • EUDAMED 93a8b3cb-2b5c-4251-8fb4-8296d2adfb5a 61 fields · synced Jul 11, 2026
  • EUDAMED 5c88929b-7698-4832-b5da-cae41df37572 61 fields · synced Jul 11, 2026
  • EUDAMED a5e2ec1d-8582-4622-93f6-51718a66d58f 61 fields · synced Jul 11, 2026
  • EUDAMED d09a09f7-950e-4d3a-9709-05b74b4d04e8 61 fields · synced Jul 12, 2026
  • EUDAMED 26828c53-8a00-4909-922e-6128590061a5 61 fields · synced Jul 12, 2026
  • EUDAMED 532f581b-b102-4e0d-8db2-6a4e0bea6de6 61 fields · synced Jul 13, 2026
  • EUDAMED 65690f43-989a-4a85-b82f-dd192084d569 61 fields · synced Jul 13, 2026
  • EUDAMED b47e4b65-f75c-43fb-b18e-54dab1f2fb77 61 fields · synced Jul 15, 2026
  • EUDAMED 4e350bb0-6a03-4b17-9c51-f721507b2e18 61 fields · synced Jul 15, 2026
  • EUDAMED e5b05d69-6de7-4b4e-acc7-700be274ab1b 61 fields · synced Jul 18, 2026
  • EUDAMED e448d083-9998-42e2-830b-83fe89291d96 61 fields · synced Jul 19, 2026
  • EUDAMED 8197a53d-7e24-4d57-b7e3-2ab41cb4508a 61 fields · synced Jul 20, 2026
  • EUDAMED 5bd07f80-6f07-47ad-9e00-4581829c750d 61 fields · synced Jul 26, 2026
  • EUDAMED 8212db23-aad5-4f0a-9b1c-a46ce5a42f21 61 fields · synced Jul 28, 2026
  • EUDAMED b5b350ce-8884-47e4-8aac-a48efa69b91b 61 fields · synced Jul 29, 2026
  • EUDAMED a2fca683-99a7-4f77-a7af-40f8940cb888 61 fields · synced Jul 30, 2026
  • EUDAMED faa0ed0a-81ad-4e46-8a0a-81a8959bc348 61 fields · synced Sep 18, 2026
  • FDA 510(k) K221176 1 fields · synced May 18, 2026