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Disposable Sterile infusion set with needle
EUDAMEDClass IIa (EU MDR)
Ref HLIVLLF08Model latex/latex free rubber injection site,with/without airvent/filte,luer lock/luer slipRef HLIVLL07
Identity
- Device Name
- Disposable Sterile infusion set with needle EUDAMED
- Model / Reference
- latex/latex free rubber injection site,with/without airvent/filte,luer lock/luer slip EUDAMEDHLIVLLF08 EUDAMEDHLIVLL07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972518340708 EUDAMED06972518340562 EUDAMED
- Basic UDI-DI
- 697251834SYQVH EUDAMED
- Direct Marketing DI
- 06972518340708 EUDAMED06972518340562 EUDAMED
- EMDN Code
- A03010101 INFUSION CONTROLLERS WITH OR W/O AIR INLET EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Sterile infusion set with needle by Changzhou Holinx Industries Co., Ltd — 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 | 697251834SYQVH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Changzhou Holinx Industries Co., Ltd
- EUDAMED SRN
- CN-MF-000041593
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (2)
- EUDAMED ebeae9ee-02f3-4231-90c8-bd376de7e47f 61 fields · synced Jul 11, 2026
- EUDAMED a3e3dbba-2cd0-42bc-8912-8befcebb1371 61 fields · synced May 18, 2026