Identity
- Trade Name
- KAWANA Safety EUDAMED
- Device Name
- Peripheral IV Catheter EUDAMED
- Model / Reference
- KAWANA EUDAMED805.K1650.SP.POI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551014890534 EUDAMED
- Basic UDI-DI
- 955101489KAWANAF9 EUDAMED
- Direct Marketing DI
- 09551014890534 EUDAMED
- EMDN Code
- C0101010201 PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS, WITH INJECTION VALVES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovakia 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
KAWANA Safety by Pentamaster MediQ Sdn. Bhd. — Class IIb — 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 | 955101489KAWANAF9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Pentamaster MediQ Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000049132
- Authorised Representative
- Europecert UG (haftungsbeschränkt) DE-AR-000004974
Sources (1)
- EUDAMED d07a2684-d5e9-48f2-93cb-26ab5a6ee527 61 fields · synced Jun 19, 2026