OffiSoins- Insulin pen needle for single use
by Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd. 2 variants
Ref HWIPN3204Model 32G(0.23mm), 31G(0.25mm), 30G(0.30mm), 29G(0.33mm)
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69586976HWYDZ001ZN 06958697619705 | Date1 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Insulin Pen Needles for Single Use
- Model / Reference
- 32G(0.23mm), 31G(0.25mm), 30G(0.30mm), 29G(0.33mm), HWIPN3204
- Primary DI / UDI-DI
- 06958697619705
- Basic UDI-DI
- 69586976HWYDZ001ZN
- EMDN Code
- A0101010202 Hypodermic pen needles, w/o safety systems
- Device Class
- Class IIa
- EU market of registration
- Belgium
Manufacturer details
- EUDAMED SRN
- CN-MF-000029789
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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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