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Safety lancet
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref NoModel XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVIII, XXX, XXXIV, XXXVIModel XXVI, XXIX, XXXIII, XXXV
Identity
- Device Name
- Safety lancet EUDAMED
- Model / Reference
- XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVIII, XXX, XXXIV, XXXVI EUDAMEDNo EUDAMEDXXVI, XXIX, XXXIII, XXXV EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138610172 EUDAMED06957138616211 EUDAMED06957138613555 EUDAMED06957138611919 EUDAMED06957138613647 EUDAMED06957138615894 EUDAMED06957138608438 EUDAMED06957138613418 EUDAMED06957138608421 EUDAMED06957138610110 EUDAMED06957138613470 EUDAMED06957138616334 EUDAMED06957138606137 EUDAMED06957138610691 EUDAMED16957138605205 EUDAMED06957138613609 EUDAMED06957138611742 EUDAMED06957138614514 EUDAMED06957138614484 EUDAMED06957138614521 EUDAMED06957138616358 EUDAMED06957138614347 EUDAMED06957138607813 EUDAMED06957138608001 EUDAMED06957138605154 EUDAMED06957138613456 EUDAMED06957138613654 EUDAMED06957138605871 EUDAMED06957138605833 EUDAMED06957138609534 EUDAMED06957138614552 EUDAMED06957138607929 EUDAMED06957138611247 EUDAMED06957138615788 EUDAMED06957138616204 EUDAMED06957138613463 EUDAMED06957138605369 EUDAMED06957138614507 EUDAMED06957138605352 EUDAMED06957138616198 EUDAMED06957138610158 EUDAMED06957138610165 EUDAMED06957138605840 EUDAMED06957138608155 EUDAMED06957138613500 EUDAMED06957138614354 EUDAMED06957138606830 EUDAMED06957138614583 EUDAMED06957138608483 EUDAMED06957138610189 EUDAMED06957138613487 EUDAMED06957138606809 EUDAMED06957138615924 EUDAMED06957138607790 EUDAMED06957138613524 EUDAMED06957138611636 EUDAMED06957138613623 EUDAMED06957138607936 EUDAMED06957138613425 EUDAMED06957138601835 EUDAMED06957138611261 EUDAMED06957138613449 EUDAMED06957138610660 EUDAMED06957138609558 EUDAMED06957138615948 EUDAMED06957138611391 EUDAMED06957138614361 EUDAMED06957138611735 EUDAMED06957138614620 EUDAMED06957138615986 EUDAMED06957138607905 EUDAMED06957138613630 EUDAMED06957138607301 EUDAMED06957138607899 EUDAMED06957138609039 EUDAMED06957138610837 EUDAMED06957138607806 EUDAMED06957138611308 EUDAMED06957138611902 EUDAMED06957138615955 EUDAMED06957138606816 EUDAMED06957138614545 EUDAMED06957138607912 EUDAMED06957138609978 EUDAMED06957138615931 EUDAMED06957138613517 EUDAMED06957138614538 EUDAMED06957138611407 EUDAMED06957138613494 EUDAMED06957138616327 EUDAMED06957138607332 EUDAMED06957138607318 EUDAMED06957138614606 EUDAMED06957138607394 EUDAMED06957138608162 EUDAMED06957138614613 EUDAMED
- Basic UDI-DI
- 69571386SL02WU EUDAMED69571386SL06X4 EUDAMED
- Unit of Use DI
- 56957138610177 EUDAMED56957138616216 EUDAMED56957138613550 EUDAMED56957138611914 EUDAMED56957138613642 EUDAMED56957138615899 EUDAMED56957138608433 EUDAMED56957138613413 EUDAMED56957138608426 EUDAMED56957138610115 EUDAMED56957138613475 EUDAMED56957138616339 EUDAMED56957138606132 EUDAMED56957138610696 EUDAMED06957138605208 EUDAMED56957138613604 EUDAMED56957138611747 EUDAMED56957138614519 EUDAMED56957138614489 EUDAMED56957138614526 EUDAMED56957138616353 EUDAMED56957138614342 EUDAMED56957138607818 EUDAMED56957138608006 EUDAMED06957138605321 EUDAMED56957138613451 EUDAMED56957138613659 EUDAMED56957138605876 EUDAMED56957138605838 EUDAMED56957138609539 EUDAMED56957138614557 EUDAMED56957138607924 EUDAMED56957138611242 EUDAMED56957138615783 EUDAMED56957138616209 EUDAMED56957138613468 EUDAMED06957138605390 EUDAMED56957138614502 EUDAMED06957138605383 EUDAMED56957138616193 EUDAMED56957138610153 EUDAMED56957138610160 EUDAMED56957138605845 EUDAMED56957138608150 EUDAMED56957138613505 EUDAMED56957138614359 EUDAMED56957138606835 EUDAMED56957138614588 EUDAMED56957138608488 EUDAMED56957138610184 EUDAMED56957138613482 EUDAMED56957138606804 EUDAMED56957138615929 EUDAMED56957138607795 EUDAMED56957138613529 EUDAMED56957138611631 EUDAMED56957138613628 EUDAMED56957138607931 EUDAMED56957138613420 EUDAMED56957138601830 EUDAMED56957138611266 EUDAMED56957138613444 EUDAMED56957138610665 EUDAMED56957138609553 EUDAMED56957138615943 EUDAMED56957138611396 EUDAMED56957138614366 EUDAMED56957138611730 EUDAMED56957138614625 EUDAMED56957138615981 EUDAMED56957138607900 EUDAMED56957138613635 EUDAMED56957138607306 EUDAMED56957138607894 EUDAMED56957138609034 EUDAMED56957138610832 EUDAMED56957138607801 EUDAMED56957138611303 EUDAMED56957138611907 EUDAMED56957138615950 EUDAMED56957138606811 EUDAMED56957138614540 EUDAMED56957138607917 EUDAMED56957138609973 EUDAMED56957138615936 EUDAMED56957138613512 EUDAMED56957138614533 EUDAMED56957138611402 EUDAMED56957138613499 EUDAMED56957138616322 EUDAMED56957138607337 EUDAMED56957138607313 EUDAMED56957138614601 EUDAMED56957138607399 EUDAMED56957138608167 EUDAMED56957138614618 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMEDFrance EUDAMEDSpain EUDAMEDItaly EUDAMEDNorthern Ireland EUDAMEDPortugal EUDAMEDAustria EUDAMEDGermany 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
Category: Blood lancet, single-use
Safety lancet by Tianjin Huahong Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251694 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220370 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69571386SL02WU | 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 (97)
- EUDAMED f84cc9d9-4dd7-437f-b079-1f627d509884 61 fields · synced Sep 18, 2026
- EUDAMED 08747936-9799-4554-8c9a-165032295d32 61 fields · synced May 11, 2026
- EUDAMED 8428aa72-0b48-4e79-88c7-fdefb8ed7fae 61 fields · synced May 16, 2026
- EUDAMED ee1e71a0-27a9-4adb-affc-a511b865f5cf 61 fields · synced May 16, 2026
- EUDAMED 80181e93-fa7a-44b9-ae43-1137bd3bd1f9 61 fields · synced May 16, 2026
- EUDAMED 053a7ba1-5e82-4666-b811-f01dfdd1f233 61 fields · synced May 16, 2026
- EUDAMED 936010c8-5e88-4072-926b-01a91d39cf88 61 fields · synced May 16, 2026
- EUDAMED f35f4989-df45-435b-9588-65bef7f2aa8c 61 fields · synced May 16, 2026
- EUDAMED ea5c401d-c3f7-4866-aa92-ea8edeb6f615 61 fields · synced May 16, 2026
- EUDAMED 8dceb01f-b03a-495e-b12e-7fcc8beb7f15 61 fields · synced May 16, 2026
- EUDAMED feefdd80-f4d8-4795-be8b-00efb97647be 61 fields · synced May 16, 2026
- EUDAMED e65ad7df-952a-46ff-8c35-b26648979e6d 61 fields · synced May 16, 2026
- EUDAMED b3862fee-6538-42ac-a756-4cfd40dccc15 61 fields · synced May 16, 2026
- EUDAMED 3480397a-cd84-49cf-b12e-d21ca8dba42d 61 fields · synced May 16, 2026
- EUDAMED f6f53e6d-68a0-46b0-b246-a4a64c34fe1c 61 fields · synced May 16, 2026
- EUDAMED bfc6b8a3-777f-46ff-a237-24fd05b40ce6 61 fields · synced May 16, 2026
- EUDAMED 8004fc77-01b0-4746-8435-ca492f3369bb 61 fields · synced May 16, 2026
- EUDAMED 5463fed5-5184-4e4d-a3b6-62a8ee2228c6 61 fields · synced May 16, 2026
- EUDAMED f03e498d-a0ea-42a0-9a61-c627e58a69ef 61 fields · synced May 16, 2026
- EUDAMED abbf9654-7681-4aff-ad75-1d48ab7d655b 61 fields · synced May 16, 2026
- EUDAMED 1cd25607-23e2-4f3a-b224-b0d9870dcbe9 61 fields · synced May 16, 2026
- EUDAMED 0f5d1847-dac2-46ac-8bc4-6dd8dff273d0 61 fields · synced May 16, 2026
- EUDAMED 0f336891-6e81-4aeb-a6e8-10114646ead3 61 fields · synced May 17, 2026
- EUDAMED ad690964-55de-44a6-be10-7e78969f8995 61 fields · synced May 17, 2026
- EUDAMED 0d26a498-1a1c-449f-8263-28c97da08c61 61 fields · synced May 17, 2026
- EUDAMED 482ccc17-bcde-406d-be27-d5261213078f 61 fields · synced May 17, 2026
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- EUDAMED 105a1e47-43f4-487f-8b69-dab492198c35 61 fields · synced May 17, 2026
- EUDAMED 55c2cbf0-d007-43e3-a467-e88343ee5a01 61 fields · synced May 17, 2026
- EUDAMED 2b7856a4-7ef8-4458-86b4-09cc1e22f4ba 61 fields · synced May 17, 2026
- EUDAMED c93beb67-8c4f-4c67-b0b0-4212b826728f 61 fields · synced May 17, 2026
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- EUDAMED 9b85459e-fce6-45b4-8167-6af42029cb31 61 fields · synced May 17, 2026
- EUDAMED d544532c-f82a-49be-a91e-d721f644bf73 61 fields · synced May 17, 2026
- EUDAMED cd106214-9f24-47a8-9b42-3cd197d1ac69 61 fields · synced May 17, 2026
- EUDAMED 964e0700-3719-455a-8a7d-53213f765698 61 fields · synced May 17, 2026
- EUDAMED c73ecdbc-a174-46ae-9c45-0d9af3b9174f 61 fields · synced May 17, 2026
- EUDAMED 157f0731-682c-49ce-895d-15f9985420ae 61 fields · synced May 17, 2026
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- EUDAMED 29ea39d9-de86-4790-8240-1c70d0960f9c 61 fields · synced May 17, 2026
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- EUDAMED f585712d-b063-4d53-aef2-5032cd6687bf 61 fields · synced May 17, 2026
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- EUDAMED 03042206-f653-4bd0-a4cc-d16bbe676c3d 61 fields · synced May 17, 2026
- EUDAMED 73a1b269-d3e0-4620-8bb2-9da42f1f8ce0 61 fields · synced May 17, 2026
- EUDAMED 50aa8a59-aa4d-4103-9c74-90ffb2c7b6bb 61 fields · synced May 17, 2026
- EUDAMED 3bc75c8b-a17d-4159-a6ea-23bb47a09682 61 fields · synced May 17, 2026
- EUDAMED 3641fb1b-26cc-4eaa-a30e-1bd984a82f3f 61 fields · synced May 17, 2026
- EUDAMED e46dc217-a178-4ac5-82f0-50dba6269587 61 fields · synced May 17, 2026
- EUDAMED a5fc33a7-acd1-4992-88ec-d74ddfec356f 61 fields · synced May 17, 2026
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- EUDAMED cb0bc619-412c-45a0-b723-43b2038d46b2 61 fields · synced May 17, 2026
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- EUDAMED 66235ffb-4aae-4fd7-a30c-38d591bb49df 61 fields · synced May 17, 2026
- EUDAMED 142047b3-bb79-4048-80a0-a2e7e8bd8901 61 fields · synced May 17, 2026
- EUDAMED bd3a7b3c-8933-41d1-9333-7b745fe17cfc 61 fields · synced May 17, 2026
- EUDAMED 9ff9ef0b-c2ca-4d38-9dff-cec3501f2357 61 fields · synced May 18, 2026
- EUDAMED 49f2e5c6-fc1f-4ca0-827a-662d44a30921 61 fields · synced Jul 8, 2026
- EUDAMED c29561c2-014e-4999-971f-27945609c341 61 fields · synced Jul 9, 2026
- EUDAMED 75bcded1-f7e5-4329-82ed-8d2e28a256ab 61 fields · synced Jul 9, 2026
- EUDAMED 33783399-a062-4d7e-ba62-3394db667e18 61 fields · synced Jul 9, 2026
- EUDAMED b4cabcc3-ee66-44eb-a447-77220e3d7893 61 fields · synced Jul 9, 2026
- EUDAMED 50501b2e-dd1b-4983-8613-359aa2aedf45 61 fields · synced Jul 10, 2026
- EUDAMED a4135d02-316c-4652-8edf-16eef6e312d7 61 fields · synced Jul 11, 2026
- EUDAMED 3d07f252-912a-409d-975e-61b57c2a0a83 61 fields · synced Jul 11, 2026
- EUDAMED 40d313cb-d0d7-43ba-b8f5-bcac8ea66391 61 fields · synced Jul 13, 2026
- EUDAMED 2bafdbfb-e3f0-406b-a98a-aa69d57ffffb 61 fields · synced Jul 15, 2026
- EUDAMED 1902d2dd-d102-4527-b449-f175e0459dee 61 fields · synced Jul 16, 2026
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- EUDAMED 1c567f1e-a5ec-48ed-ac9a-9c5ea97eabc8 61 fields · synced Jul 17, 2026
- EUDAMED b5138e52-d7cc-429e-af37-3ae56add7798 61 fields · synced Jul 17, 2026
- EUDAMED b70c3f0f-61e8-4380-8b04-7221cb305bf0 61 fields · synced Jul 18, 2026
- EUDAMED 82876fc1-e193-46fa-90e0-c94e8613207f 61 fields · synced Jul 20, 2026
- EUDAMED 5c03cea2-3afd-4795-ab4d-b87534e2b9ac 61 fields · synced Jul 20, 2026
- EUDAMED 2715c368-8aa5-4211-8a0c-f0012c462c7e 61 fields · synced Jul 21, 2026
- EUDAMED 79ff078b-4ffe-48c1-964e-95b0591eb615 61 fields · synced Jul 21, 2026
- EUDAMED 314e3d26-9788-4313-b9b5-ad76f24ae190 61 fields · synced Jul 23, 2026
- EUDAMED 20bf9823-e9a7-4c23-b4b1-f11eb5722ce6 61 fields · synced Jul 24, 2026
- EUDAMED c84a2051-0212-4f1c-bed2-00e2880d093b 61 fields · synced Jul 28, 2026
- EUDAMED fdeaa5ef-e419-4c7d-a2d2-b94074df3b62 61 fields · synced Jul 29, 2026
- EUDAMED f5b32fe4-5d47-4fa6-8687-17fe8c91da92 61 fields · synced Jul 30, 2026
- EUDAMED fa877c70-b47b-419c-9409-79158bb7eb2c 61 fields · synced Jul 30, 2026
- EUDAMED f0764d5e-f303-4730-91a8-dcddc6ab79e3 61 fields · synced Jul 30, 2026
- EUDAMED 727dc1c2-030e-45d2-9803-d5d33b945fdd 61 fields · synced Jul 31, 2026
- EUDAMED 713d12e6-a96b-43e5-85c3-4bbccd53c378 61 fields · synced Jul 31, 2026
- EUDAMED 80003714-84a2-479e-9fac-4a48e1b32c7e 61 fields · synced Jul 31, 2026
- EUDAMED 2e080315-facc-499c-8ba2-0bdef0d68cd1 61 fields · synced Aug 1, 2026
- EUDAMED 7baa2d11-f7d5-4254-8f40-072b77d91a7f 61 fields · synced Aug 3, 2026
- EUDAMED d23e8f81-0b7e-45a2-aa0f-cccf48fd5db7 61 fields · synced Aug 3, 2026
- EUDAMED 1df5cd93-433a-441e-970e-dd22fb674b9e 61 fields · synced Aug 4, 2026
- EUDAMED c744e950-598a-4105-894c-0db823e41954 61 fields · synced Aug 4, 2026
- EUDAMED 7141f2d9-e2a4-4826-98ea-aeb48beecfd9 61 fields · synced Sep 18, 2026
- FDA 510(k) K251694 1 fields · synced May 18, 2026