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Verifine
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref /Ref SL-28-18Model Type A, Type B, Type C, Type T, Type MRef SPN-31-5Ref SL-30-12MRef SL-23-18M2510(k) K192666Ref BL-30G
Identity
- Trade Name
- Verifine EUDAMED
- Device Name
- Alcohol Swabs EUDAMEDSafety Blood Lancets EUDAMEDsafety pen needle EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- / EUDAMEDType A, Type B, Type C, Type T, Type M EUDAMEDSL-28-18 EUDAMEDSPN-31-5 EUDAMEDSL-30-12M EUDAMEDSL-23-18M2 EUDAMEDBL-30G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965299926 EUDAMED06971227400314 EUDAMED06971227401816 EUDAMED06971227402417 EUDAMED06971227408754 EUDAMED06975965293238 EUDAMED
- Basic UDI-DI
- 697122740ALSNP EUDAMED697122740SLYU EUDAMED697122740SPNRK EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86975965299922 EUDAMED86971227400310 EUDAMED86971227401812 EUDAMED86971227402413 EUDAMED86971227408750 EUDAMED86975965293234 EUDAMED
- 510(k) Number
- K192666 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
- EMDN Code
- M0202030102 NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMEDV010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDA0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMEDV010402 LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Market of Registration
- Czechia EUDAMEDSweden EUDAMEDGermany EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Verifine by Promisemed Hangzhou Meditech Co., Ltd. — Class I — 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192666 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697122740ALSNP | Class I | 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 (7)
- EUDAMED 19864eb7-53bf-407a-8147-a7124e267d9b 61 fields · synced Oct 6, 2026
- EUDAMED 719a3099-544c-4a41-b305-3b5e18ecd931 61 fields · synced May 16, 2026
- EUDAMED 3494c927-39b7-4265-93af-3b41c6ccf2c3 61 fields · synced May 17, 2026
- EUDAMED 428a5459-8d9d-46c2-9041-29f137650c06 61 fields · synced May 17, 2026
- EUDAMED 75acff81-d9a7-4d5b-9ed9-d9143ef84379 61 fields · synced May 18, 2026
- FDA 510(k) K192666 24 fields · synced May 18, 2026
- EUDAMED feac8004-e560-4a3f-bae0-8bacc2c0a6b1 61 fields · synced Sep 17, 2026