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Pen Needle
EUDAMEDClass IIa (EU MDR)
Ref CT-3108Model CT, CTW, CR, CF, CFW, CFRRef CT-3008Ref CT-3204Ref CT-3105Ref CT-3205
Identity
- Trade Name
- Pen Needle EUDAMED
- Device Name
- Disposable Insulin Pen Needle EUDAMED
- Model / Reference
- CT, CTW, CR, CF, CFW, CFR EUDAMEDCT-3108 EUDAMEDCT-3008 EUDAMEDCT-3204 EUDAMEDCT-3105 EUDAMEDCT-3205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16934047905695 EUDAMED16934047905664 EUDAMED16934047905701 EUDAMED16934047905671 EUDAMED16934047905718 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 (5)
- EUDAMED fe2753f5-caf8-41ba-95aa-423a1371e709 61 fields · synced Jul 30, 2026
- EUDAMED fc515221-e27a-4d5f-85dd-5451e1f82862 61 fields · synced May 17, 2026
- EUDAMED 07d7dd9f-289f-4040-a473-5882576cdbcc 61 fields · synced May 17, 2026
- EUDAMED bf09c01a-fb51-4b31-a925-d328aa116fc1 61 fields · synced May 18, 2026
- EUDAMED c1023dcf-5c12-47a7-8231-89885eedc1b6 61 fields · synced Jul 30, 2026