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Syringes for single use [ 20mL 18G*1" (1.2mm*25mm), Luer Slip ]
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref S20S1825Model 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL
Identity
- Trade Name
- Syringes for single use [ 20mL 18G*1" (1.2mm*25mm), Luer Slip ] EUDAMEDSterile Single-use Syringe with Needle FDA UDI
- Generic Name
- General-purpose syringe/needle FDA UDI
- Device Name
- Syringes for single use EUDAMED
- Model / Reference
- 1mL、2mL、2.5 mL、3 mL、5 mL、10 mL、20 mL、30 mL、50 mL、60 mL、100 mL EUDAMEDS20S1825 EUDAMED20mL LS 18G×1" (1.2mm×25mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06920756728796 EUDAMEDFDA UDI
- Basic UDI-DI
- 69207567ZSQ0001ZR EUDAMED
- 510(k) Number
- K163161 FDA UDI
- FDA Product Code
- FMI FDA UDIFMF FDA UDI
- EMDN Code
- A02010499 SYRINGES FOR INJECTOR, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- General-purpose syringe/needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI880.5860 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMEDFDA UDI
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Syringes for single use [ 20mL 18G1" (1.2mm25mm), Luer Slip ] by Jiangxi Hongda Medical Equipment Group Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69207567ZSQ0001ZR | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Jiangxi Hongda Medical Equipment Group Ltd.
- EUDAMED SRN
- CN-MF-000006019
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED fef3192e-768f-4ee2-a5ba-108b2e30b6ab 61 fields · synced Oct 6, 2026
- FDA UDI d16d35cd-7509-40a7-a03c-35ad32439b80 33 fields · synced May 30, 2026