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51 cm (20") Quadfuse Add-On Set w/3 ProSeal Injector, x4 Clamps, w/Twist-off po…
EUDAMEDClass I (EU MDR)
Ref 423330
Identity
- Trade Name
- 51 cm (20") Quadfuse Add-On Set w/3 ProSeal Injector,x4 Clamps, w/Twist-off port EUDAMED
- Device Name
- Gravity Administration Sets, Extension Sets, Irrigation Sets EUDAMED
- Model / Reference
- 423330 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18859299133338 EUDAMED
- Basic UDI-DI
- 88592991B009UL EUDAMED
- EMDN Code
- A070103 INFUSION TUBING ADAPTERS AND CONNECTORS EUDAMED
Classification
- Device Class
- Class I 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
51 cm (20") Quadfuse Add-On Set w/3 ProSeal Injector, x4 Clamps, w/Twist-off po… by Epic International (Thailand) Co., Ltd. — Class I — MDR — listed in EUDAMED
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 | 88592991B009UL | Class I | Active |
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Manufacturer
- Manufacturer
- Epic International (Thailand) Co., Ltd.
- EUDAMED SRN
- TH-MF-000012102
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED c3e0fe77-14d3-4bdb-ae74-b6344d0e526a 61 fields · synced Oct 7, 2026