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Hypodermic Syringe with needle
EUDAMEDClass I (EU MDR)
Ref 51061Model Hypodermic Syringe
Identity
- Trade Name
- Hypodermic Syringe with needle EUDAMED
- Device Name
- Hypodermic Syringe EUDAMED
- Model / Reference
- Hypodermic Syringe EUDAMED51061 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095510612 EUDAMED
- Basic UDI-DI
- 890209551064FB EUDAMED
- EMDN Code
- A020102020102 INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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 Syringe with needle by Poly Medicure Limited — Class I — 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 | 890209551064FB | Class I | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000043011
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED eb33a5b4-33c0-4e93-9d32-4cbc08d2713a 61 fields · synced Jun 19, 2026