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bexen medical
EUDAMEDClass IIa (EU MDR)
Ref PS3105Model Disposable Safety Insulin Pen Needles
Identity
- Trade Name
- bexen medical EUDAMED
- Model / Reference
- Disposable Safety Insulin Pen Needles EUDAMEDPS3105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 56971564463015 EUDAMED
- Basic UDI-DI
- 69715644600410ZQ EUDAMED
- Unit of Use DI
- 46971564463018 EUDAMED
- EMDN Code
- A0101010201 HYPODERMIC PEN NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
bexen medical by Jiangsu Caina 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 | 69715644600410ZQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 777e3e15-48c0-4110-80c8-58c7112cc48d 61 fields · synced Jun 18, 2026