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Aghi monouso sterili pen penna da insulina
EUDAMEDClass IIa (EU MDR)
Ref CT-3104Model CT, CTW, CR, CF, CFW, CFRRef CT-3206
Identity
- Trade Name
- Aghi monouso sterili pen penna da insulina EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT, CTW, CR, CF, CFW, CFR EUDAMEDCT-3104 EUDAMEDCT-3206 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047991322 EUDAMED06934047991332 EUDAMED06934047991325 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 pen 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 (3)
- EUDAMED b9e3b070-d505-49be-ac50-504c79433127 61 fields · synced Jul 26, 2026
- EUDAMED 618e570a-bcea-4a8c-aeaa-3768ec2d513f 61 fields · synced Jul 19, 2026
- EUDAMED 9a67f855-eb84-4138-8321-3f44e7626477 61 fields · synced Jul 26, 2026