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Pen Needle
EUDAMEDClass IIa (EU MDR)
Ref CT-2912Model CT, CTW, CR, CF, CFW, CFR
Identity
- Trade Name
- Pen Needle EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT, CTW, CR, CF, CFW, CFR EUDAMEDCT-2912 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905657 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
- 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
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 | 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 64abf983-0182-492b-9d56-a933dd44d50f 61 fields · synced May 23, 2026