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Safety insulin pen needle
EUDAMEDClass IIa (EU MDR)
Ref SFINE-631Model safety type
Identity
- Trade Name
- Safety insulin pen needle EUDAMED
- Device Name
- Safety Insulin Pen Needle EUDAMED
- Model / Reference
- safety type EUDAMEDSFINE-631 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923033453688 EUDAMED
- Basic UDI-DI
- 69230334202002a01902N2 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH 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
Safety insulin pen needle by Zhejiang Kindly Medical Devices 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 | 69230334202002a01902N2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007594
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED f4ab83fc-9bbb-4043-bcc4-6c22829dacb4 61 fields · synced Oct 5, 2026