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Pen Needle
EUDAMEDClass IIa (EU MDR)
Ref NoModel Type V, Type XModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IXModel Type I, Type IB, Type VI
Identity
- Device Name
- Pen Needle EUDAMED
- Model / Reference
- Type V, Type X EUDAMEDNo EUDAMEDType II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX EUDAMEDType I, Type IB, Type VI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138614972 EUDAMED06957138612770 EUDAMED06957138609510 EUDAMED06957138612749 EUDAMED06957138610530 EUDAMED06957138610554 EUDAMED06957138610516 EUDAMED06957138614828 EUDAMED06957138615412 EUDAMED06957138615085 EUDAMED06957138612411 EUDAMED06957138612817 EUDAMED06957138615405 EUDAMED06957138612190 EUDAMED06957138615702 EUDAMED06957138612480 EUDAMED06957138615399 EUDAMED06957138613258 EUDAMED06957138613401 EUDAMED06957138610493 EUDAMED06957138612626 EUDAMED06957138609053 EUDAMED06957138612510 EUDAMED06957138611599 EUDAMED06957138612732 EUDAMED06957138613296 EUDAMED06957138612978 EUDAMED06957138613241 EUDAMED06957138614897 EUDAMED06957138612695 EUDAMED06957138614989 EUDAMED06957138615108 EUDAMED06957138609480 EUDAMED06957138613265 EUDAMED06957138615061 EUDAMED06957138613388 EUDAMED06957138612176 EUDAMED06957138612640 EUDAMED06957138613111 EUDAMED06957138612121 EUDAMED06957138612398 EUDAMED06957138612671 EUDAMED06957138613005 EUDAMED06957138612572 EUDAMED06957138610547 EUDAMED06957138612688 EUDAMED06957138613319 EUDAMED06957138611575 EUDAMED06957138613272 EUDAMED06957138615139 EUDAMED06957138612374 EUDAMED06957138615115 EUDAMED06957138612763 EUDAMED06957138615122 EUDAMED06957138610523 EUDAMED06957138612541 EUDAMED06957138612657 EUDAMED06957138615023 EUDAMED06957138612404 EUDAMED06957138611384 EUDAMED06957138612664 EUDAMED06957138610585 EUDAMED06957138613098 EUDAMED06957138612787 EUDAMED06957138615177 EUDAMED06957138614941 EUDAMED06957138612824 EUDAMED06957138615306 EUDAMED06957138612558 EUDAMED06957138615016 EUDAMED06957138610509 EUDAMED
- Basic UDI-DI
- 69571386PD09VD EUDAMED69571386PD08VB EUDAMED69571386PD07V9 EUDAMED
- Unit of Use DI
- 56957138614977 EUDAMED56957138612775 EUDAMED56957138609515 EUDAMED56957138612744 EUDAMED56957138610535 EUDAMED56957138610559 EUDAMED56957138610511 EUDAMED56957138614823 EUDAMED56957138615417 EUDAMED56957138615080 EUDAMED56957138612416 EUDAMED56957138612812 EUDAMED56957138615400 EUDAMED56957138612195 EUDAMED56957138615707 EUDAMED56957138612485 EUDAMED56957138615394 EUDAMED56957138613253 EUDAMED56957138613406 EUDAMED56957138610498 EUDAMED56957138612621 EUDAMED56957138609058 EUDAMED56957138612515 EUDAMED56957138611594 EUDAMED56957138612737 EUDAMED56957138613291 EUDAMED56957138612973 EUDAMED56957138613246 EUDAMED56957138614892 EUDAMED56957138612690 EUDAMED56957138614984 EUDAMED56957138615103 EUDAMED56957138609485 EUDAMED56957138613260 EUDAMED56957138615066 EUDAMED56957138613383 EUDAMED56957138612171 EUDAMED56957138612645 EUDAMED56957138613116 EUDAMED56957138612126 EUDAMED56957138612393 EUDAMED56957138612676 EUDAMED56957138613000 EUDAMED56957138612577 EUDAMED56957138610542 EUDAMED56957138612683 EUDAMED56957138613314 EUDAMED56957138611570 EUDAMED56957138613277 EUDAMED56957138615134 EUDAMED56957138612379 EUDAMED56957138615110 EUDAMED56957138612768 EUDAMED56957138615127 EUDAMED56957138610528 EUDAMED56957138612546 EUDAMED56957138612652 EUDAMED56957138615028 EUDAMED56957138612409 EUDAMED56957138611389 EUDAMED56957138612669 EUDAMED56957138610580 EUDAMED56957138613093 EUDAMED56957138612782 EUDAMED56957138615172 EUDAMED56957138614946 EUDAMED56957138612829 EUDAMED56957138615301 EUDAMED56957138612553 EUDAMED56957138615011 EUDAMED56957138610504 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDFrance EUDAMEDAustria 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
Pen Needle by Tianjin Huahong Technology Co., Ltd. — Class IIa — 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 | 69571386PD09VD | Class IIa | Active |
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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 (71)
- EUDAMED 97166963-5195-4b61-922b-d89bcdfcea90 61 fields · synced Sep 18, 2026
- EUDAMED de00dd7b-2a50-4070-8d22-55151c03368d 61 fields · synced May 11, 2026
- EUDAMED f36c5041-60ef-42e3-8b20-5ac91f4bf596 61 fields · synced May 11, 2026
- EUDAMED 05eb0105-ae0e-4417-94cc-22cac6411698 61 fields · synced May 11, 2026
- EUDAMED 073a8113-149c-4953-a3c7-7a45cbc13a7a 61 fields · synced May 11, 2026
- EUDAMED 10897a81-a050-41f9-84f3-bef558f4607c 61 fields · synced May 11, 2026
- EUDAMED 139c4294-fe0c-48c7-91cb-0eb50b090378 61 fields · synced May 11, 2026
- EUDAMED 171832e6-a33d-402b-a07a-83721be13ed7 61 fields · synced May 11, 2026
- EUDAMED 17f1a007-2939-4731-9177-6260e02e2726 61 fields · synced May 11, 2026
- EUDAMED 8c5882fa-4faa-4646-9a93-94974932375d 61 fields · synced May 16, 2026
- EUDAMED 6a154725-26ae-4c45-8011-914b10e04f53 61 fields · synced May 16, 2026
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- EUDAMED caa395eb-f48f-4e10-8198-f3107046075c 61 fields · synced May 17, 2026
- EUDAMED f750a8fb-5f95-498a-903b-e31cb1bd59c5 61 fields · synced May 17, 2026
- EUDAMED 6c836829-90e6-44d2-84f1-79dd0287e38d 61 fields · synced May 17, 2026
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- EUDAMED 5f4d7f87-d780-4e63-b268-495ec0e17dbc 61 fields · synced May 17, 2026
- EUDAMED 84142aad-294f-4a34-80f6-73444181131c 61 fields · synced May 17, 2026
- EUDAMED 48a1182a-99ed-48ef-b1a6-0587ad549e91 61 fields · synced May 17, 2026
- EUDAMED ea123455-f31b-4c12-821b-92bdbe8e3017 61 fields · synced May 17, 2026
- EUDAMED 16e8ec72-edb6-4577-92bc-7c7d2a72bc49 61 fields · synced May 17, 2026
- EUDAMED 1403ea2e-810d-428d-9bf0-5ffdee855222 61 fields · synced May 17, 2026
- EUDAMED bb351743-0846-489b-ad9f-baa639fa48ac 61 fields · synced May 17, 2026
- EUDAMED 8fc3933c-05df-4036-96a2-f6f305573aff 61 fields · synced May 17, 2026
- EUDAMED a64ef3ba-76a2-436e-b3b1-ade8b8e94c76 61 fields · synced May 17, 2026
- EUDAMED 95cd0b1b-102c-4f9c-ad15-68c98a57ac9c 61 fields · synced May 17, 2026
- EUDAMED 329f1bd7-aedd-4090-beb1-935c065afa80 61 fields · synced May 17, 2026
- EUDAMED b8e92fa0-ca6b-4dd4-bfcc-963b3b939fb6 61 fields · synced May 17, 2026
- EUDAMED 531cb01c-e05b-4ba6-b915-864f7ed1d7db 61 fields · synced May 17, 2026
- EUDAMED 3038e2b4-72f1-4995-8740-ef342ce1ce55 61 fields · synced May 17, 2026
- EUDAMED 171088fe-eccd-44aa-aa83-528a46eddd25 61 fields · synced Jul 8, 2026
- EUDAMED 44a7fe48-97db-4ee9-a7d3-b6467d123b10 61 fields · synced Jul 8, 2026
- EUDAMED b4dbcd0f-e794-4ea1-8fe2-185f4cbea7e7 61 fields · synced Jul 9, 2026
- EUDAMED 3767f155-1306-459f-a1aa-2a0f51810b3d 61 fields · synced Jul 9, 2026
- EUDAMED 07f3c1f7-a49a-46ae-92e4-289f60210ba1 61 fields · synced Jul 9, 2026
- EUDAMED 41004c7f-693f-4a36-95a6-7af3af60ecf6 61 fields · synced Jul 9, 2026
- EUDAMED 5fa43305-3d40-4b62-b6a9-2bd2b28320d5 61 fields · synced Jul 9, 2026
- EUDAMED 3cf252c3-104a-4d61-af7a-ffbc77bc6cd7 61 fields · synced Jul 9, 2026
- EUDAMED 899d26ce-f8c9-41fe-ae6d-3dade0b6047c 61 fields · synced Jul 10, 2026
- EUDAMED beee8428-ceb9-4a0c-93c4-2550527c4a19 61 fields · synced Jul 12, 2026
- EUDAMED cdb28098-7073-40b4-86ec-256ae3e3a1f2 61 fields · synced Jul 13, 2026
- EUDAMED 6defeb33-54a7-46f0-8658-53b78331cbfe 61 fields · synced Jul 14, 2026
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- EUDAMED f12a8921-70be-4fbd-8844-951cd9e478aa 61 fields · synced Jul 16, 2026
- EUDAMED 0bf7eb33-373e-4cdd-8ab9-743e15060b55 61 fields · synced Jul 17, 2026
- EUDAMED bbc5680b-b5e6-41bf-b1a6-61d647420e47 61 fields · synced Jul 19, 2026
- EUDAMED b379a5ab-c356-4e59-977c-e73f7027ef90 61 fields · synced Jul 20, 2026
- EUDAMED a557c518-d7ef-4066-94bd-0e40fe262bcf 61 fields · synced Jul 20, 2026
- EUDAMED dfcae96e-327b-43fd-ab73-f71264148566 61 fields · synced Jul 21, 2026
- EUDAMED 77d9bf97-0270-4af7-814e-6ebd19c1bb36 61 fields · synced Jul 21, 2026
- EUDAMED 08935254-6f44-4835-a941-7f34635f429f 61 fields · synced Jul 22, 2026
- EUDAMED 4001a4e2-2858-447b-a7ec-a63bfd48efef 61 fields · synced Jul 25, 2026
- EUDAMED 1e9e8b0c-b4f5-47e2-b914-7b335e18754e 61 fields · synced Jul 26, 2026
- EUDAMED 5a3c4f27-9825-4253-8458-fafb9bfbc2e8 61 fields · synced Jul 28, 2026
- EUDAMED 87415ade-4e8b-4417-aeb1-4e3d7206f8c5 61 fields · synced Jul 31, 2026
- EUDAMED 123ef56a-cb09-48cf-aeb9-5c39c41941bb 61 fields · synced Aug 1, 2026
- EUDAMED bf00e832-ffc6-466a-b1a7-7214b76ba21d 61 fields · synced Aug 1, 2026
- EUDAMED 2cf8a7de-3531-4579-accc-57e5671f3e8d 61 fields · synced Aug 2, 2026
- EUDAMED 6496447d-70eb-448a-a811-9e283f5065eb 61 fields · synced Aug 2, 2026