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Aghi monouso sterili per penna da insulina
EUDAMEDClass IIa (EU MDR)
Ref CT-3105Model CT, CTW, CR, CF, CFW, CFR
Identity
- Trade Name
- Aghi monouso sterili per penna da insulina EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT, CTW, CR, CF, CFW, CFR EUDAMEDCT-3105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06934047990748 EUDAMED
- Basic UDI-DI
- 69340479EU13RX EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Aghi monouso sterili per penna da insulina 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 | 69340479EU13RX | 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 (1)
- EUDAMED eade4813-4a81-48d8-9cd1-48ecfdfa90cd 61 fields · synced Jun 18, 2026