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KAWANA Safety
EUDAMEDClass IIb (EU MDR)
Ref 805.K1845.SF.KOIModel KAWANARef 805.K1650.SP.PRIRef 805.K1833.SF.PRIRef 805.K2033.SP.KOIRef 805.K1650.SFRef 805.K1845.SFRef 805.K2025.SP.POIRef 805.K2225.SFRef 805.K1450.SPRef 805.K2033.SP.PRIRef 805.K1650.SP.KOIRef 805.K2033.SPRef 805.K2225.SPRef 805.K1833.SFRef 805.K1845.SPRef 805.K1845.SP.PRIRef 805.K1450.SF.KOIRef 805.K1833.SF.KOIRef 805.K1450.SF.PRIRef 805.K1450.SF.POIRef 805.K2033.SP.POIRef 805.K2033.SFRef 805.K2419.SFRef 805.K1833.SPRef 805.K1650.SF.POIRef 805.K2033.SF.PRIRef 805.K1845.SP.POIRef 805.K1833.SP.KOIRef 805.K2419.SPRef 805.K2419.SF.KOIRef 805.K2225.SP.POIRef 805.K2033.SF.HSSRef 805.K1845.SF.HSSRef 805.K2419.SF.PRIRef 805.K2225.SF.POIRef 805.K2225.SP.KOIRef 805.K1450.SF.HSSRef 805.K2419.SP.POIRef 805.K2225.SF.PRI
Identity
- Trade Name
- KAWANA Safety EUDAMED
- Device Name
- Peripheral IV Catheter EUDAMED
- Model / Reference
- KAWANA EUDAMED805.K1845.SF.KOI EUDAMED805.K1650.SP.PRI EUDAMED805.K1833.SF.PRI EUDAMED805.K2033.SP.KOI EUDAMED805.K1650.SF EUDAMED805.K1845.SF EUDAMED805.K2025.SP.POI EUDAMED805.K2225.SF EUDAMED805.K1450.SP EUDAMED805.K2033.SP.PRI EUDAMED805.K1650.SP.KOI EUDAMED805.K2033.SP EUDAMED805.K2225.SP EUDAMED805.K1833.SF EUDAMED805.K1845.SP EUDAMED805.K1845.SP.PRI EUDAMED805.K1450.SF.KOI EUDAMED805.K1833.SF.KOI EUDAMED805.K1450.SF.PRI EUDAMED805.K1450.SF.POI EUDAMED805.K2033.SP.POI EUDAMED805.K2033.SF EUDAMED805.K2419.SF EUDAMED805.K1833.SP EUDAMED805.K1650.SF.POI EUDAMED805.K2033.SF.PRI EUDAMED805.K1845.SP.POI EUDAMED805.K1833.SP.KOI EUDAMED805.K2419.SP EUDAMED805.K2419.SF.KOI EUDAMED805.K2225.SP.POI EUDAMED805.K2033.SF.HSS EUDAMED805.K1845.SF.HSS EUDAMED805.K2419.SF.PRI EUDAMED805.K2225.SF.POI EUDAMED805.K2225.SP.KOI EUDAMED805.K1450.SF.HSS EUDAMED805.K2419.SP.POI EUDAMED805.K2225.SF.PRI EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09551014890596 EUDAMED09551014890459 EUDAMED09551014890671 EUDAMED09551014890855 EUDAMED09551014891272 EUDAMED09551014890008 EUDAMED09551014891012 EUDAMED09551014890046 EUDAMED09551014891289 EUDAMED09551014890817 EUDAMED09551014890497 EUDAMED09551014890084 EUDAMED09551014890107 EUDAMED09551014890015 EUDAMED09551014890060 EUDAMED09551014890572 EUDAMED09551014890350 EUDAMED09551014890718 EUDAMED09551014890312 EUDAMED09551014890398 EUDAMED09551014890893 EUDAMED09551014890022 EUDAMED09551014890053 EUDAMED09551014890077 EUDAMED09551014890510 EUDAMED09551014890794 EUDAMED09551014890657 EUDAMED09551014890732 EUDAMED09551014890114 EUDAMED09551014891197 EUDAMED09551014891135 EUDAMED09551014892255 EUDAMED09551014892248 EUDAMED09551014891159 EUDAMED09551014891111 EUDAMED09551014891098 EUDAMED09551014892224 EUDAMED09551014891258 EUDAMED09551014891036 EUDAMED
- Basic UDI-DI
- 955101489KAWANAF9 EUDAMED
- Direct Marketing DI
- 09551014890596 EUDAMED09551014890459 EUDAMED09551014890671 EUDAMED09551014890855 EUDAMED09551014891272 EUDAMED09551014890008 EUDAMED09551014891012 EUDAMED09551014890046 EUDAMED09551014891289 EUDAMED09551014890817 EUDAMED09551014890497 EUDAMED09551014890084 EUDAMED09551014890107 EUDAMED09551014890015 EUDAMED09551014890060 EUDAMED09551014890572 EUDAMED09551014890350 EUDAMED09551014890718 EUDAMED09551014890312 EUDAMED09551014890398 EUDAMED09551014890893 EUDAMED09551014890022 EUDAMED09551014890053 EUDAMED09551014890077 EUDAMED09551014890510 EUDAMED09551014890794 EUDAMED09551014890657 EUDAMED09551014890732 EUDAMED09551014890114 EUDAMED09551014891197 EUDAMED09551014891135 EUDAMED09551014892255 EUDAMED09551014892248 EUDAMED09551014891159 EUDAMED09551014891111 EUDAMED09551014891098 EUDAMED09551014892224 EUDAMED09551014891258 EUDAMED09551014891036 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 (39)
- EUDAMED 4b824a20-ed58-4e85-8a52-5e31b41a57e2 61 fields · synced Sep 17, 2026
- EUDAMED fde2fb47-db4e-4322-9aaf-5eb21df64ba6 61 fields · synced May 11, 2026
- EUDAMED f132c517-b821-4e5f-acbc-75b2dbda426d 61 fields · synced May 16, 2026
- EUDAMED ce351816-70e7-4a0e-9b3e-127ac0929b5b 61 fields · synced May 16, 2026
- EUDAMED 62458508-0016-43df-ad3e-0a1e92435200 61 fields · synced May 16, 2026
- EUDAMED 7120f072-9a66-499e-b793-0ea71d8ed3ff 61 fields · synced May 16, 2026
- EUDAMED 3c29d699-2d4f-41c2-9b51-9ced9c86fd24 61 fields · synced May 16, 2026
- EUDAMED 3135f790-e817-4fad-8fd3-a83cc4e6102c 61 fields · synced May 17, 2026
- EUDAMED 877bab55-480d-48df-b415-580b2deb46e3 61 fields · synced May 17, 2026
- EUDAMED abedb4a2-d3ba-4f0d-9224-516f9d50e003 61 fields · synced May 17, 2026
- EUDAMED 6a9a61a4-6e94-458d-9f65-195a26d97c0d 61 fields · synced May 17, 2026
- EUDAMED e7928ce1-68dd-48fb-9c95-6217f3684e72 61 fields · synced May 17, 2026
- EUDAMED b27bab19-44f5-49c8-83ea-d84e5f951171 61 fields · synced May 17, 2026
- EUDAMED 87be0c54-3b38-4a05-8f0b-615745f6f4e0 61 fields · synced May 17, 2026
- EUDAMED b3ea50d1-00f0-4eab-a877-1150afe74f5e 61 fields · synced May 17, 2026
- EUDAMED 920d5da8-83c2-4990-bed3-b3db422fc63e 61 fields · synced May 17, 2026
- EUDAMED f19f77bc-ca76-43ea-914a-92d91497bcd3 61 fields · synced May 18, 2026
- EUDAMED 50c716cc-56b9-4bf2-945b-b78e49fe8898 61 fields · synced May 18, 2026
- EUDAMED 8a1c6ac0-3ca6-4e86-947f-62fdd3a08e87 61 fields · synced May 18, 2026
- EUDAMED c5280d81-e5d4-4032-abb9-40fe72f9fe4c 61 fields · synced May 18, 2026
- EUDAMED 23eaa536-e320-4ab0-94fb-88b83048b641 61 fields · synced May 18, 2026
- EUDAMED 24a30d85-d654-43fd-a919-cb4b0f0a82ef 61 fields · synced May 18, 2026
- EUDAMED 4ca57adf-6069-460c-972e-50cd049fc83a 61 fields · synced May 18, 2026
- EUDAMED ef7a270d-8655-4edf-9ec6-0e4dd3e528f8 61 fields · synced May 18, 2026
- EUDAMED 04eda099-b74b-41e6-a217-c2a7022bd69f 61 fields · synced May 18, 2026
- EUDAMED a5539d0b-fa7f-4144-8c45-0f8ffc148876 61 fields · synced May 18, 2026
- EUDAMED 2dda86f2-b1d3-487a-b1e1-32611022a67e 61 fields · synced May 19, 2026
- EUDAMED 83d36764-9f8b-4fe9-aee2-5d8476018604 61 fields · synced May 19, 2026
- EUDAMED 79b7f6da-d998-4e2b-9e25-d32a8b704caa 61 fields · synced May 19, 2026
- EUDAMED 5c8504d1-8b7e-4b2c-a79a-7f359f3f796b 61 fields · synced Jul 8, 2026
- EUDAMED 5cee6f5a-0c66-4906-afaa-41256160dfa0 61 fields · synced Jul 17, 2026
- EUDAMED b4346741-5a24-4ef3-b717-12a12ad56844 61 fields · synced Jul 17, 2026
- EUDAMED 60ed206b-20a7-4bef-8f92-75ebab2ef865 61 fields · synced Jul 21, 2026
- EUDAMED 6d2586b1-4ea5-4875-9315-e8d9ad935819 61 fields · synced Jul 22, 2026
- EUDAMED 4f32316c-9534-4632-8a73-3d5dbd2e84c3 61 fields · synced Jul 22, 2026
- EUDAMED cee64b4d-f582-42f0-ae41-ce9a8f3e7642 61 fields · synced Jul 23, 2026
- EUDAMED 6427d972-95c8-4fa9-9a83-4a19bf1c87f7 61 fields · synced Jul 28, 2026
- EUDAMED 4ee89acd-0407-4e4c-8339-adc9ee9f19bb 61 fields · synced Jul 28, 2026
- EUDAMED 8d9a3e48-7568-47ab-953d-50d713362696 61 fields · synced Aug 3, 2026