Klinion
by Genray Hangzhou Life Technology Co., Ltd. EUDAMED
Active
Ref 5277, 5269, 5266, 5260, 5295, 5290, 5278, 5261, 5291, 5264, 5279, 5268
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697510050IPNNQ | Date2 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Insulin Pen NeedlesX-Safety pen needle
- Model / Reference
- 5277, 5269, 5266, 5260, 5295, 5290, 5278, 5261, 5291, 5264, 5279, 5268
- Primary DI / UDI-DI
- 06975100501068, 06975100500221, 06975100500269, 06975100500276, 06975100500153, 06975100500313, 06975100500160, 06975100500351, 06975100501099, 06975100500283, 06975100500375, 06975100500139, 06975100501266, 06975100500146, 06975100500306, 06975100500177
- Basic UDI-DI
- 697510050IPNNQ, 697510050XPNR3
- Unit of Use DI
- 86975100501064, 86975100500227, 86975100500265, 86975100500272, 86975100500159, 86975100500319, 86975100500166, 86975100500357, 86975100501095, 86975100500289, 86975100500371, 86975100500135, 86975100501262, 86975100500142, 86975100500302, 86975100500173
- EMDN Code
- A0101010202, A0101010201
- Device Class
- Class IIa
- Market of Registration
- SwedenNetherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000038113
- Authorised representative
- Obelis s.a. BE-AR-000000106
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Properties
Show properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Measuring Function: No
- Incorporates Medicinal Product: No