Sterile Syringe with Safety Needle for Single Use, 1ml syringe, 25Gx25mm needle
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Sterile Syringe with Safety Needle for Single Use, 1ml syringe, 25Gx25mm needle EUDAMED
- Device Name
- Sterile Syringe with Safety Needle for Single Use, EUDAMED
- Model / Reference
- Sterile Syringe with Safety Needle for Single Use, EUDAMEDSY012525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16955356113038 EUDAMED
- Basic UDI-DI
- 69553561SYDEN2G EUDAMED
- Direct Marketing DI
- 16955356113038 EUDAMED
- EMDN Code
- A02010205 INFUSION AND IRRIGATION SYRINGES WITH SAFETY SYSTEM, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
Measuring Function
No
Incorporates Medicinal Product
No
This device is a sterile syringe with safety needle for single use, classified under nomenclature code A02010205 as a medical device for administering medicines. It features a 1ml syringe paired with a 25G x 25mm needle designed to minimize post-use needlestick risk through an integrated safety mechanism.
The device is intended for single-use only and supplied in a sterile condition, adhering to FDA 510K and MDR regulatory requirements. It is non-reusable, non-implantable, and latex-free, with a Basic UDI of 69553561SYDEN2G. Storage and handling must comply with sterile medical device protocols to maintain integrity.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GEMTIER MEDICAL (SHANGHAI) INC. SY012525 Gemtier - RevMed, AccessGUDID - DEVICE: Gemtier (06955356111471), AccessGUDID - DEVICE: Gemtier (06955356111440), Sterile Syringe with Safety needle for Single Use, Sterile Syringe for ..., Amazon.com: 1ml 25G Syringe with Needle,Disposable Sterile Syringe 100pcs
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212949 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K183665 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K192679 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212920 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69553561SYDEN2G | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gemtier Medical (Shanghai) Inc.
- EUDAMED SRN
- CN-MF-000003835
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 08b36478-d9e2-4f79-84e8-4877bda9b711 61 fields · synced Sep 18, 2026
- FDA 510(k) K212949 1 fields · synced May 18, 2026