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Verifine
EUDAMEDClass IIa (EU MDR)
Ref SL-21-24M2Model Type A, Type B, Type C, Type T, Type MRef SL-28-18M2Ref NPN-32*4Model IPN-32-4Ref IPN-32-4QRef MIS-033008-100Model Type 7,Type 7-u100,Type 7-u40,
Identity
- Trade Name
- Verifine EUDAMED
- Device Name
- Safety Blood Lancets EUDAMEDInsulin Pen Needles EUDAMEDSafety Insulin Syringe;Safety Syringe with Fixed Needle EUDAMED
- Model / Reference
- Type A, Type B, Type C, Type T, Type M EUDAMEDSL-21-24M2 EUDAMEDSL-28-18M2 EUDAMEDIPN-32-4 EUDAMEDNPN-32*4 EUDAMEDIPN-32-4Q EUDAMEDType 7,Type 7-u100,Type 7-u40, EUDAMEDMIS-033008-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965290725 EUDAMED06978111923539 EUDAMED06971227407153 EUDAMED06975965290268 EUDAMED06975965291920 EUDAMED
- Basic UDI-DI
- 697122740SLYU EUDAMED697122740IPNPZ EUDAMED697122740MISQA EUDAMED
- Unit of Use DI
- 86975965290721 EUDAMED86978111923535 EUDAMED86971227407159 EUDAMED86975965290264 EUDAMED86975965291926 EUDAMED
- EMDN Code
- V010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE EUDAMEDA0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDA02010601 INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMEDPoland EUDAMEDDenmark 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 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 (5)
- EUDAMED efe49c9a-7b89-486e-b069-c40fa726939d 61 fields · synced Oct 5, 2026
- EUDAMED b39ecdeb-f879-414d-b20d-a3427a45e6df 61 fields · synced May 18, 2026
- EUDAMED e830cae3-f229-4afb-b07e-ccc19709ed1d 61 fields · synced Jul 15, 2026
- EUDAMED e41965d5-9cff-4ea7-89b0-f4d3354685d1 61 fields · synced Jul 18, 2026
- EUDAMED d1e3f624-5ba6-40d9-a082-c578c1f0600e 61 fields · synced Jul 22, 2026