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Huber Infusion Set with Safety
EUDAMEDClass IIa (EU MDR)
Ref 95125Model Huber Infusion Set (Huber Needle) with/without Safety
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 EUDAMED95125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902095951255 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 — 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 | 890209595001GT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Poly Medicure Limited
- EUDAMED SRN
- IN-MF-000003380
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 5e90feb7-f92b-4eef-a245-1b7c365ea9e3 61 fields · synced Jun 19, 2026