Identity
- Device Name
- Sterile Single I.V. Catheters EUDAMED
- Model / Reference
- 96-38 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806102630204 EUDAMED
- Basic UDI-DI
- 880610260003BB EUDAMED
- EMDN Code
- C0104020205 PHARMACEUTICAL INFUSION AND ADMINISTRATION INTRAVASCULAR CATHETERS AND MICROCATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
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
Sterile Single I.V. Catheters by Korea Vaccine 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 | 880610260003BB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Korea Vaccine co., Ltd.
- EUDAMED SRN
- KR-MF-000028066
- Authorised Representative
- Certification Experts NL-AR-000000235
Sources (1)
- EUDAMED b32cae99-2c38-41a4-9190-254b927f29fb 61 fields · synced Jun 19, 2026