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Verifine
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref SL-21-18TModel Type A, Type B, Type C, Type T, Type MRef BL-30GRef SL-21-18Ref SL-21-22TRef SL-28-15M2Ref SL-30-18M2Ref IPN-31-5RModel IPN-32-4Ref IPN-32-6Ref SL-21-18MRef SL-30-15M2Ref SL-23-24Ref IPN-33-5Ref IPN-31-8Ref IPN-33-4Ref SL-28-18TRef SL-26-18Ref IPN-31-6QRef IPN-31-8RRef SL-30-16Ref SL-23-18TRef IPN-32-5Ref SPN-31-5Ref IPN-31-5QRef IPN-32-8QRef SL-30-18TRef SL-28-16MRef SL-30-16TRef SPN-30-6Ref BL-30ERef SL-21-24MRef IPN-31-8QRef SPN-30-5Ref SL-30-15MRef SL-28-16Ref SL-30-16MRef SL-21-24M2Ref IPN-32-4RRef SL-30-16M2Ref IPN-34-5Ref IPN-30-10Ref IPN-29-8
Identity
- Trade Name
- Verifine EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDBlood Lancets EUDAMEDInsulin Pen Needles EUDAMEDsafety pen needle EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-21-18T EUDAMEDBL-30G EUDAMEDSL-21-18 EUDAMEDSL-21-22T EUDAMEDSL-28-15M2 EUDAMEDSL-30-18M2 EUDAMEDIPN-32-4 EUDAMEDIPN-31-5R EUDAMEDIPN-32-6 EUDAMEDSL-21-18M EUDAMEDSL-30-15M2 EUDAMEDSL-23-24 EUDAMEDIPN-33-5 EUDAMEDIPN-31-8 EUDAMEDIPN-33-4 EUDAMEDSL-28-18T EUDAMEDSL-26-18 EUDAMEDIPN-31-6Q EUDAMEDIPN-31-8R EUDAMEDSL-30-16 EUDAMEDSL-23-18T EUDAMEDIPN-32-5 EUDAMEDSPN-31-5 EUDAMEDIPN-31-5Q EUDAMEDIPN-32-8Q EUDAMEDSL-30-18T EUDAMEDSL-28-16M EUDAMEDSL-30-16T EUDAMEDSPN-30-6 EUDAMEDBL-30E EUDAMEDSL-21-24M EUDAMEDIPN-31-8Q EUDAMEDSPN-30-5 EUDAMEDSL-30-15M EUDAMEDSL-28-16 EUDAMEDSL-30-16M EUDAMEDSL-21-24M2 EUDAMEDIPN-32-4R EUDAMEDSL-30-16M2 EUDAMEDIPN-34-5 EUDAMEDIPN-30-10 EUDAMEDIPN-29-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971227400659 EUDAMED06975965294624 EUDAMED06971227400284 EUDAMED06971227401892 EUDAMED06975965292446 EUDAMED06971227409706 EUDAMED06975965290527 EUDAMED06971227402332 EUDAMED06971227401113 EUDAMED06975965292453 EUDAMED06971227401403 EUDAMED06975965296635 EUDAMED06971227400239 EUDAMED06971227401762 EUDAMED06971227405272 EUDAMED06971227402257 EUDAMED06971227400307 EUDAMED06975965290244 EUDAMED06971227400093 EUDAMED06971227402028 EUDAMED06975965294631 EUDAMED06975965290541 EUDAMED06971227400369 EUDAMED06978111923492 EUDAMED06971227401748 EUDAMED06971227403803 EUDAMED06971227407184 EUDAMED06975965299742 EUDAMED06971227402059 EUDAMED06971227402318 EUDAMED06971227405753 EUDAMED06971227402073 EUDAMED06971227402097 EUDAMED06971227407412 EUDAMED06971227401120 EUDAMED06971227407207 EUDAMED06971227402080 EUDAMED06971227401175 EUDAMED06971227400871 EUDAMED06971227400352 EUDAMED06971227405814 EUDAMED06971227409683 EUDAMED06971227401793 EUDAMED06975965290510 EUDAMED06975965296130 EUDAMED06971227400253 EUDAMED06978111923508 EUDAMED06971227401298 EUDAMED06971227407801 EUDAMED06971227404046 EUDAMED06975965296666 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740BLX9 EUDAMED697122740IPNPZ EUDAMED697122740SPNRK EUDAMED
- Unit of Use DI
- 86971227400655 EUDAMED86975965294620 EUDAMED86971227400280 EUDAMED86971227401898 EUDAMED86975965292442 EUDAMED86971227409702 EUDAMED86975965290523 EUDAMED86971227402338 EUDAMED86971227401119 EUDAMED86975965292459 EUDAMED86971227401409 EUDAMED86975965296631 EUDAMED86971227400235 EUDAMED86971227401768 EUDAMED86971227405278 EUDAMED86971227402253 EUDAMED86971227400303 EUDAMED86975965290240 EUDAMED86971227400099 EUDAMED86971227402024 EUDAMED86975965294637 EUDAMED86975965290547 EUDAMED86971227400365 EUDAMED86978111923498 EUDAMED86971227401744 EUDAMED86971227403809 EUDAMED86971227407180 EUDAMED86975965299748 EUDAMED86971227402055 EUDAMED86971227402314 EUDAMED86971227405759 EUDAMED86971227402079 EUDAMED86971227402093 EUDAMED86971227407418 EUDAMED86971227401126 EUDAMED86971227407203 EUDAMED86971227402086 EUDAMED86971227401171 EUDAMED86971227400877 EUDAMED86971227400358 EUDAMED86971227405810 EUDAMED86971227409689 EUDAMED86971227401799 EUDAMED86975965290516 EUDAMED86975965296136 EUDAMED86971227400259 EUDAMED86978111923504 EUDAMED86971227401294 EUDAMED86971227407807 EUDAMED86971227404042 EUDAMED86975965296662 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDA0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Blood lancet, single-use
Verifine by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Blood lancet, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K221368 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 697122740SLYU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (52)
- EUDAMED 4fb85855-41ef-4364-ae43-cb211a6db9c5 61 fields · synced Oct 6, 2026
- EUDAMED 6f43d903-b472-4d80-af06-eff9b309c8fe 61 fields · synced May 11, 2026
- EUDAMED b11a6c53-0653-4b91-aad9-eed5d6224f7c 61 fields · synced May 11, 2026
- EUDAMED fdc0da21-ac4f-4d36-8393-24d464be5eb2 61 fields · synced May 11, 2026
- EUDAMED 0e2f742b-4e61-49c1-9bfb-01473a01bb3c 61 fields · synced May 11, 2026
- EUDAMED 15e9c4d9-06d6-43d1-85da-fc35c5068594 61 fields · synced May 11, 2026
- EUDAMED 991fb3d1-d86c-4c99-941a-5279dba1230b 61 fields · synced May 16, 2026
- EUDAMED 9d77f79e-12b4-4720-80eb-b818e64e898f 61 fields · synced May 16, 2026
- EUDAMED e7148eb2-34f6-4dea-948c-77039fd49524 61 fields · synced May 16, 2026
- EUDAMED 50f023d5-145b-4e59-95a0-4ce7280da5d6 61 fields · synced May 16, 2026
- EUDAMED ab92447d-ade9-4d6d-9327-6cbcb4312214 61 fields · synced May 16, 2026
- EUDAMED 6d982fd6-28dc-4209-9626-73f11876b5d3 61 fields · synced May 16, 2026
- EUDAMED 987951e2-cd67-4778-ac99-e320464571c4 61 fields · synced May 16, 2026
- EUDAMED cccd1ee3-4904-420d-b996-cdd1e93eb38e 61 fields · synced May 16, 2026
- EUDAMED 65750c69-6e50-44a3-aa24-63e1b0784955 61 fields · synced May 16, 2026
- EUDAMED add1e56c-ad92-4191-bc2e-3f0c9075b569 61 fields · synced May 16, 2026
- EUDAMED 2e2068b1-446c-4a98-9721-7870703821ef 61 fields · synced May 16, 2026
- EUDAMED 9dd0f785-7e45-4759-ba4a-2cbde095527c 61 fields · synced May 16, 2026
- EUDAMED 8bcb1bc3-e650-4d96-8a19-638334bb81c6 61 fields · synced May 16, 2026
- EUDAMED 4c7fd5bb-9c5a-41d6-890e-c2037e3833d7 61 fields · synced May 16, 2026
- EUDAMED 8c2657bc-b72b-4cbf-85f6-1eba85e029b1 61 fields · synced May 17, 2026
- EUDAMED 5187075c-1052-4c84-a4d8-b3d612aeccf1 61 fields · synced May 17, 2026
- EUDAMED bed03f0a-9810-4245-bb56-94b51b23a794 61 fields · synced May 17, 2026
- EUDAMED 3571d403-e2c3-4c2d-8826-57ddc198334b 61 fields · synced May 17, 2026
- EUDAMED 096b65d1-1c13-4fef-a1c7-f8e7627a287f 61 fields · synced May 17, 2026
- EUDAMED 72235614-e4df-488c-b0b8-3a9059ce7f45 61 fields · synced May 17, 2026
- EUDAMED cd73db5f-5d11-4207-b47f-71f2efcd86c5 61 fields · synced May 17, 2026
- EUDAMED 3f572df1-fe30-4051-8375-6fc70c7ff0f0 61 fields · synced May 17, 2026
- EUDAMED 7ea5bb61-04f0-4e1e-9d1c-cda2ef25fbe3 61 fields · synced May 17, 2026
- EUDAMED 3b28ebd6-b00d-429b-9194-ee3f2daef3ac 61 fields · synced May 17, 2026
- EUDAMED 4dde17a9-94ff-4291-b5a6-7d4e614b0ec4 61 fields · synced May 17, 2026
- EUDAMED 750e28a3-e837-4507-89c1-7d335c2045d1 61 fields · synced May 17, 2026
- EUDAMED 4d3af5c9-1abc-4ea0-89b8-ba29ddd6f996 61 fields · synced May 17, 2026
- EUDAMED 6f14942c-fa18-483b-a7ac-d2b43a0c116e 61 fields · synced May 17, 2026
- EUDAMED 0422b5f0-7985-4cff-b1e0-0b5685c52ec8 61 fields · synced May 17, 2026
- EUDAMED 3a58760e-2d7a-4345-bda3-616828be44d0 61 fields · synced May 17, 2026
- EUDAMED 44f1e348-0ea8-4ed6-9a13-a29d2284457a 61 fields · synced May 17, 2026
- EUDAMED 061a21f0-d602-491c-97b0-1a0d66aa7116 61 fields · synced May 17, 2026
- EUDAMED 86f9e6b5-0ca4-463c-8372-96d85dc31662 61 fields · synced May 17, 2026
- EUDAMED d6f43191-b824-4f1a-9b93-6a3938fd95d3 61 fields · synced May 17, 2026
- EUDAMED f7028f68-2d34-46cf-a159-edd629d3d467 61 fields · synced May 17, 2026
- EUDAMED 48a4f83c-cd57-42b8-b518-12274d7adc34 61 fields · synced May 17, 2026
- EUDAMED dac68821-dad1-4d43-8f20-3bf768602dc0 61 fields · synced May 17, 2026
- EUDAMED 58d82c72-fed0-4ed5-b45e-8537813f8b3c 61 fields · synced May 17, 2026
- EUDAMED 0d8a605c-c086-4c39-ae0c-e0eecc3533a0 61 fields · synced May 17, 2026
- EUDAMED c2110439-9861-4b08-9111-e0e63c141eab 61 fields · synced May 17, 2026
- EUDAMED b74d219d-0989-4582-b89e-c60c0bb577bb 61 fields · synced May 17, 2026
- EUDAMED 8cdd8e4f-cb14-40e6-b9e2-5ff24a061638 61 fields · synced May 17, 2026
- EUDAMED 2116a8cf-adc7-49df-b141-d5ce271d8324 61 fields · synced May 17, 2026
- EUDAMED 7b64a09b-de59-4d8d-94c6-314a27ec1ba2 61 fields · synced May 17, 2026
- EUDAMED 7e39129c-fafc-42d0-9632-7b34120de4b9 61 fields · synced May 17, 2026
- FDA 510(k) K221368 1 fields · synced May 18, 2026