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Hypodermic Needle with/without Safety features
EUDAMEDClass IIa (EU MDR)
Ref 91630Model Hypodermic Needle with/without Safety Features
Identity
- Trade Name
- Hypodermic Needle with/without Safety features EUDAMED
- Device Name
- Hypodermic Needle with/without Safety Features EUDAMED
- Model / Reference
- Hypodermic Needle with/without Safety Features EUDAMED91630 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095916308 EUDAMED
- Basic UDI-DI
- 890209591631H6 EUDAMED
- EMDN Code
- A0101010101 HYPODERMIC SYRINGE NEEDLES, WITH SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Hypodermic Needle with/without Safety features by Poly Medicure Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890209591631H6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly medicure limited
- EUDAMED SRN
- IN-MF-000043010
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED d1716535-f6dd-4e7a-8447-69324c758c8d 61 fields · synced Jun 18, 2026