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Dual Safety Pen Needle
EUDAMEDClass IIa (EU MDR)
Ref SD-3008Model SD, SDWRef SD-3005
Identity
- Trade Name
- Dual Safety Pen Needle EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- SD, SDW EUDAMEDSD-3008 EUDAMEDSD-3005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047906029 EUDAMED16934047906012 EUDAMED
- Basic UDI-DI
- 69340479EU19SDMW 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
Dual Safety Pen Needle by Ningbo Medsun Medical 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 | 69340479EU19SDMW | 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 67cd6b7c-6789-4868-9052-eaf45a17c845 61 fields · synced Sep 17, 2026
- EUDAMED d37a69f4-d9ec-4407-904e-b60a201ee814 61 fields · synced May 18, 2026