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Sterile Hypodermic Needle 16GX1''
EUDAMEDClass IIa (EU MDR)
Ref IT-00-46-SNModel SOLOJEKT HYPODERMIC
Identity
- Device Name
- Sterile Hypodermic Needle 16GX1'' EUDAMED
- Model / Reference
- SOLOJEKT HYPODERMIC EUDAMEDIT-00-46-SN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06118002223007 EUDAMED
- Basic UDI-DI
- 611800222HYPONDLEL EUDAMED
- EMDN Code
- A0101010102 HYPODERMIC SYRINGE NEEDLES, W/O 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
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 Needle 16GX1'' by I'M Medicare SARL — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Hypodermic Needles
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 611800222HYPONDLEL | Class IIa | Active |
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Manufacturer
- Manufacturer
- I'M Medicare SARL
- EUDAMED SRN
- MA-MF-000037665
- Authorised Representative
- EUCEREP B.V. NL-AR-000001966
Sources (1)
- EUDAMED 0bd1aef3-32fa-43e4-98a7-1e19b1549bd8 61 fields · synced Jun 18, 2026