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Sterile Hypodermic Syringes for Single Use
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref ZSQ167Model XXml LS W/O NEEDLE
Identity
- Device Name
- Sterile Hypodermic Syringes for Single Use EUDAMED
- Model / Reference
- XXml LS W/O NEEDLE EUDAMEDZSQ167 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16944425861680 EUDAMED
- Basic UDI-DI
- 69444258ZSQLS383 EUDAMED
- Unit of Use DI
- 06944425861683 EUDAMED
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sterile Hypodermic Syringes for Single Use by Jiangsu Kangyou Medical Instrument Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211728 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69444258ZSQLS383 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiangsu Kangyou Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000027474
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED bd03d91b-c210-4238-9326-2822850b33b4 61 fields · synced Oct 6, 2026
- FDA 510(k) K211728 1 fields · synced May 18, 2026