Identity
- Trade Name
- SOLUDIAB EUDAMED
- Device Name
- Insulin Pen Needles EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN-31-8 EUDAMEDIPN-32-5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975965291401 EUDAMED06975965290930 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 86975965291407 EUDAMED86975965290936 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Soludiab 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 (2)
- EUDAMED b62ea331-8780-4f58-91b8-b16032ecf9fe 61 fields · synced Jul 27, 2026
- EUDAMED 34f7dfab-0b85-4fa5-bd26-2530481db41a 61 fields · synced May 19, 2026