BATIST Sterile insulin syringe for single use without needle U-40 1ml
by Anhui Hongyu Wuzhou Medical Manufacturer CO., Ltd.
Ref 1321610820, 1321610821
Active
CE MDR 510(k)
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number69586976HWINS002V5 | Date6 May 2026 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK230061 | Date30 Nov 2023 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Trade Name
- BATIST Sterile insulin syringe for single use without needle U-40 1mlBATIST Sterile insulin syringe for single use without needle U-100 1ml
- Device Name
- Sterile Insulin Syringes for Single Use
- Model / Reference
- 1321610820, 1321610821
- Primary DI / UDI-DI
- 06958697607467, 06958697607474
- Basic UDI-DI
- 69586976HWINS002V5
- EMDN Code
- A02010602 Insulin syringes w/o fixed needles, single-use
- Device Class
- Class IIa
- EU market of registration
- Czechia
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 (10)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Incorporates Medicinal Product: No