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Huber Infusion Set with Safety
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 95123Model Huber Infusion Set (Huber Needle) with/without Safety510(k) K200463
Identity
- Trade Name
- Huber Infusion Set with Safety EUDAMED
- Device Name
- Huber Infusion Set with safety EUDAMED
- Model / Reference
- Huber Infusion Set (Huber Needle) with/without Safety EUDAMED95123 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095951231 EUDAMED
- Basic UDI-DI
- 890209595001GT EUDAMED
- EMDN Code
- A01010301 NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT), 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
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
Huber Infusion Set with Safety by Poly Medicure Limited — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200463 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 890209595001GT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- FDA Applicant
- Jiangsu Caina Medical Co.,Ltd
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 1936bd1b-94bd-43e7-9d83-599b3c810d17 85 fields · synced Jun 19, 2026
- FDA 510(k) K200463 1 fields · synced May 18, 2026