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Sterile Hypodermic Safety Syringe with Needle (Clip Type)
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref E0001Model 1mL
Identity
- Device Name
- Sterile Hypodermic Safety Syringe with Needle (Clip Type) EUDAMED
- Model / Reference
- 1mL EUDAMEDE0001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906067660299 EUDAMED
- Basic UDI-DI
- B-08906067660299 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Hypodermic needle, single-use
Sterile Hypodermic Safety Syringe with Needle (Clip Type) by Lifelong Meditech Private Limited — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k)
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Also classified as Hypodermic needle, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222925 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08906067660299 | 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 622610e0-012d-4d95-9af5-bc77a5881758 61 fields · synced Jun 19, 2026
- FDA 510(k) K222925 1 fields · synced May 18, 2026