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Aiguille à usage unique pour stylo à insuline ClassiFine®
EUDAMEDClass IIa (EU MDR)
Ref CFINE-831Model CT, CTW, CR, CF, CFW, CFR
Identity
- Trade Name
- Aiguille à usage unique pour stylo à insuline ClassiFine® EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT, CTW, CR, CF, CFW, CFR EUDAMEDCFINE-831 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047990639 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
- 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 ClassiFine® 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 | 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 1f3b8d2f-bd79-4fcb-8726-77d86e1e92fc 61 fields · synced Jun 18, 2026