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Safety Pen Needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ST-3008Model ST, STW510(k) K253622
Identity
- Trade Name
- Safety Pen Needle EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- ST, STW EUDAMEDST-3008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905749 EUDAMED
- Basic UDI-DI
- 69340479EU12RV EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark 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
Safety Pen Needle by Ningbo Medsun Medical Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253622 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69340479EU12RV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ningbo Medsun Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011842
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 6008067a-3d3a-482d-8e68-b03ce178e2b9 85 fields · synced Jun 18, 2026
- FDA 510(k) K253622 1 fields · synced May 18, 2026