Identity
- Device Name
- Pen Needle EUDAMED
- Model / Reference
- Type V, Type X EUDAMEDNo EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957138610783 EUDAMED
- Basic UDI-DI
- 69571386PD09VD EUDAMED
- Unit of Use DI
- 56957138610788 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
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 | 69571386PD09VD | 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 e7c62441-a088-415b-b555-eaeadb50273a 61 fields · synced May 23, 2026