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Insulin pen needle
EUDAMEDClass IIa (EU MDR)
Ref NoModel Type I, Type IB, Type VI
Identity
- Device Name
- Insulin pen needle EUDAMED
- Model / Reference
- Type I, Type IB, Type VI EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138616044 EUDAMED
- Basic UDI-DI
- 69571386PN03WK EUDAMED
- Unit of Use DI
- 56957138616049 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Insulin pen needle by Tianjin Huahong Technology 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 | 69571386PN03WK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Tianjin Huahong Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000015849
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 88fc7db1-194d-4ca2-9999-45af08606999 61 fields · synced May 23, 2026