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Aiguille à usage unique pour stylo à insuline SecurFine2®
EUDAMEDClass IIa (EU MDR)
Ref SFINE2-631Model ST, STWRef SFINE2-531
Identity
- Trade Name
- Aiguille à usage unique pour stylo à insuline SecurFine2® EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- ST, STW EUDAMEDSFINE2-631 EUDAMEDSFINE2-531 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047990646 EUDAMED16934047990578 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
- France 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
Aiguille à usage unique pour stylo à insuline SecurFine2® by Ningbo Medsun Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 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 73e82d9e-0991-409b-b5f6-e35f8984e42f 61 fields · synced Jul 18, 2026
- EUDAMED 691cfc35-1c56-4476-9504-fe37a7249d7b 61 fields · synced May 17, 2026