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Pen needle
EUDAMEDClass IIa (EU MDR)
Ref NoModel Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX
Identity
- Device Name
- Pen needle EUDAMED
- Model / Reference
- Type II, Type IIIA, Type IIIB, Type IV, Type VII, Type VIII, Type IX EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138612831 EUDAMED
- Basic UDI-DI
- 69571386PD08VB EUDAMED
- Unit of Use DI
- 56957138612836 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 | 69571386PD08VB | 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 6b0b00ec-1fc4-4b3d-8e7b-5e6305f81fe0 61 fields · synced May 23, 2026