← Back to catalogue
Direct
EUDAMEDClass IIa (EU MDR)
Ref IPN32*4Model IPN-32-4Ref IPN31*5Ref BL-30G
Identity
- Trade Name
- Direct EUDAMED
- Device Name
- Insulin Pen Needles EUDAMEDBlood Lancets EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN32*4 EUDAMEDIPN31*5 EUDAMEDBL-30G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965297175 EUDAMED06975965297144 EUDAMED06975965292842 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED697122740BLX9 EUDAMED
- Unit of Use DI
- 86975965297171 EUDAMED86975965297140 EUDAMED86975965292848 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMEDV010402 LANCETS WITHOUT 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
Direct 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 3360044e-8a92-4d12-8482-147eb84636e0 61 fields · synced Oct 6, 2026
- EUDAMED 39c5b66b-8f30-4dee-a247-beef0b75fdac 61 fields · synced May 16, 2026
- EUDAMED b4fae2af-31b7-4fbe-b2ac-cd3c078ee149 61 fields · synced May 17, 2026