evercare
by Genray Hangzhou Life Technology Co., Ltd. EUDAMED
Active
Ref 1972908, 1973306, 1973005, 1973206, 1973305, 1973008, 1973205, 1973006, 1973106, 1972905
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- Withdrawn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 Needles
- Model / Reference
- 1972908, 1973306, 1973005, 1973206, 1973305, 1973008, 1973205, 1973006, 1973106, 1972905
- Primary DI / UDI-DI
- 06975100500429, 06975100500566, 06975100500436, 06975100500528, 06975100500559, 06975100500450, 06975100500511, 06975100500443, 06975100500481, 06975100500405
- Basic UDI-DI
- 697510050IPNNQ
- Unit of Use DI
- 86975100500425, 86975100500562, 86975100500432, 86975100500524, 86975100500555, 86975100500456, 86975100500517, 86975100500449, 86975100500487, 86975100500401
- EMDN Code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device Class
- Class IIa
- Market of Registration
- Sweden
Manufacturer details
- EUDAMED SRN
- CN-MF-000038113
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from Genray Hangzhou Life Technology Co., Ltd.
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Properties
Show properties
Other properties (12)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No