GlucoRx
by Genray Hangzhou Life Technology Co., Ltd. China EUDAMED
Ref 1463005BC
EMDN A0101010201
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697510050XPNR3 | Date3 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- X-Safety pen needle
- Model / Reference
- 1463005BC
- Primary DI / UDI-DI
- 06975100500641
- Basic UDI-DI
- 697510050XPNR3
- Unit of Use DI
- 86975100500647
- EMDN Code
- A0101010201 Hypodermic pen needles, with safety systems
- Device Class
- Class IIa
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000038113
- Authorised representative
- Obelis s.a. BE-AR-000000106
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED eb07c8cf-9cff-445d-b25d-5c9c6c2512f5