Identity
- Trade Name
- Pen Needle EUDAMED
- Device Name
- Pen Needle EUDAMED
- Model / Reference
- YDSZT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06951592199150 EUDAMED
- Basic UDI-DI
- 69515921FT4701JB EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The Pen Needle device is a Class IIa medical device used for the administration of medication directly into the bloodstream, offering a sterile and controlled environment for precise dosing. This reusable device features a stainless steel needle with a syringe-like design, allowing for easy reusability and minimizing contamination risk.
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 | 69515921FT4701JB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Beijing Fert Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009737
- Authorised Representative
- Lepu Medical (Europe) Cooperatief U.A. NL-AR-000000551
Sources (1)
- EUDAMED 0ddb3873-b89d-4730-aea1-f85dcfc72abf 61 fields · synced Oct 7, 2026