Identity
- Trade Name
- Alphacheck EUDAMED
- Device Name
- Insulin Pen Needles EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN31*6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971227402561 EUDAMED06971227403704 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 86971227402567 EUDAMED86971227403700 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
Alphacheck by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — CE/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 ce2d32e6-d01b-47e1-a777-128819eed781 61 fields · synced Oct 7, 2026
- EUDAMED a5c26d59-ae4a-4751-912d-aff67f33bb8c 61 fields · synced May 18, 2026