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Safeway
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref A1382Model 1mL,2mL, 2.5mL,3mL,5mL,10mL,20mL,50mL and 60mL510(k) K210103
Identity
- Trade Name
- Safeway EUDAMED
- Device Name
- Sterile hypodermice syringe with and without needle EUDAMED
- Model / Reference
- 1mL,2mL, 2.5mL,3mL,5mL,10mL,20mL,50mL and 60mL EUDAMEDA1382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906158781117 EUDAMED
- Basic UDI-DI
- 890615878LML001LU EUDAMED
- 510(k) Number
- K210103 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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
Safeway by Lifelong Meditech Private Limited — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 890615878LML001LU | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K210103 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 890615878LML001LU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lifelong Meditech Private Limited
- EUDAMED SRN
- IN-MF-000013835
- Authorised Representative
- Meddevices Lifesciences B.V. NL-AR-000000594
Sources (2)
- EUDAMED 27811df8-427a-4b2d-b87b-c901ed85f83a 61 fields · synced Jul 23, 2026
- FDA 510(k) K210103 24 fields · synced May 18, 2026