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NeonVerifine
EUDAMEDClass IIa (EU MDR)
Ref IPN-31-8Model IPN-32-4Ref SPN-31-5Ref SL-30-18M2Model Type A, Type B, Type C, Type T, Type MRef SL-28-18MRef IPN-32-6Ref IPN-31-4
Identity
- Trade Name
- NeonVerifine EUDAMED
- Device Name
- Insulin Pen Needles EUDAMEDsafety pen needle EUDAMEDSafety Blood Lancets EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN-31-8 EUDAMEDSPN-31-5 EUDAMEDType A, Type B, Type C, Type T, Type M EUDAMEDSL-30-18M2 EUDAMEDSL-28-18M EUDAMEDIPN-32-6 EUDAMEDIPN-31-4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965290008 EUDAMED06971227407948 EUDAMED06978111921450 EUDAMED06971227407924 EUDAMED06978111923072 EUDAMED06971227407863 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED697122740SPNRK EUDAMED697122740SLYU EUDAMED
- Unit of Use DI
- 86975965290004 EUDAMED86971227407944 EUDAMED86978111921456 EUDAMED86971227407920 EUDAMED86978111923078 EUDAMED86971227407869 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDA0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMEDV010401 LANCETS WITH SAFETY SYSTEMS, SINGLE-USE 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
Yes
EUDAMEDEUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
NeonVerifine by Promisemed Hangzhou Meditech 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 | 697122740IPNPZ | 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 (6)
- EUDAMED daf5766f-2f28-44d1-9f67-633cbe77fa6f 61 fields · synced Oct 6, 2026
- EUDAMED 99466017-ea72-497b-9a96-909e778eb319 61 fields · synced May 17, 2026
- EUDAMED 8b280fb4-8894-436b-bdd7-d27a08af877c 61 fields · synced May 17, 2026
- EUDAMED a0d840b9-7e92-461c-8de9-2bb2899721c8 61 fields · synced May 18, 2026
- EUDAMED 577011af-3fa9-479f-a83e-8d2cd4b473ea 61 fields · synced May 18, 2026
- EUDAMED 53377b50-f929-4982-a1c6-9d44071a401c 61 fields · synced May 18, 2026