← Back to catalogue
Aghimonouso Per Penna Da Insulina
EUDAMEDClass IIa (EU MDR)
Ref /Model CT 0.25mm(31G)×4mmRef CT-3104-40Model CT, CTW, CR, CF, CFW, CFR
Identity
- Trade Name
- AGHIMONOUSO PER PENNA DA INSULINA EUDAMEDAghi monouso sterili per penna da insulina EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT 0.25mm(31G)×4mm EUDAMED/ EUDAMEDCT, CTW, CR, CF, CFW, CFR EUDAMEDCT-3104-40 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047993715 EUDAMED
- Basic UDI-DI
- B-16934047993715 EUDAMED69340479EU13RX 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
Aghimonouso Per Penna Da Insulina by Ningbo Medsun Medical Co., Ltd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-16934047993715 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-16934047993715 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
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 56109c22-7b12-4a01-8ded-e68512313b9f 61 fields · synced Jul 26, 2026
- EUDAMED d93353bb-48ea-40c2-ac7a-69f294fecca0 61 fields · synced May 19, 2026