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Intravenous Start Kit
EUDAMEDClass IIa (EU MDR)
Ref 061PC09146ARef 061PC09000ARef 061PC09135ARef 061PC09046ARef 061PC09081ARef 061PC09116ARef 061PC09029ARef 061PC09080ARef 061PC09083ARef 061PC09134ARef 061PC09084ARef 061PC09047ARef 061PC09144ARef 061PC09089ARef 061PC09148A
Identity
- Trade Name
- Intravenous Start Kit EUDAMED
- Device Name
- Intravenous Starter Kit EUDAMEDIntravenous Start Kit EUDAMEDIV Start Kit EUDAMED
- Model / Reference
- 061PC09146A EUDAMED061PC09000A EUDAMED061PC09135A EUDAMED061PC09046A EUDAMED061PC09081A EUDAMED061PC09116A EUDAMED061PC09029A EUDAMED061PC09080A EUDAMED061PC09083A EUDAMED061PC09134A EUDAMED061PC09084A EUDAMED061PC09047A EUDAMED061PC09144A EUDAMED061PC09089A EUDAMED061PC09148A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240405050 EUDAMED09555240403322 EUDAMED09555240404237 EUDAMED09555240405951 EUDAMED09555240404336 EUDAMED09555240403452 EUDAMED09555240404954 EUDAMED09555240404183 EUDAMED09555240404374 EUDAMED09555240404312 EUDAMED09555240405357 EUDAMED09555240403360 EUDAMED09555240406958 EUDAMED09555240407054 EUDAMED09555240407085 EUDAMED09555240407078 EUDAMED09555240406903 EUDAMED
- Basic UDI-DI
- B-09555240405050 EUDAMEDB-09555240403322 EUDAMEDB-09555240404237 EUDAMED955524040IV1SGG EUDAMEDB-09555240403452 EUDAMEDB-09555240404954 EUDAMEDB-09555240404312 EUDAMEDB-09555240405357 EUDAMEDB-09555240403360 EUDAMED955524040IVSPR EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Medical Purpose
- The procedure pack provides the necessary items, required to prepare the skin for an IV cannula insertion and fixation. 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Intravenous Start Kit by Itl Asia Pacific Sdn. Bhd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-09555240405050 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-09555240405050 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (17)
- EUDAMED 8aeaf64a-8f5d-42fa-a1e2-9852a5ae0e5f 61 fields · synced Sep 18, 2026
- EUDAMED c0530c45-219c-446e-a318-800961827185 61 fields · synced May 17, 2026
- EUDAMED 9dd0b5ae-3da2-433b-8cd7-92ea1c11afc0 61 fields · synced May 17, 2026
- EUDAMED b3eb6a6e-9095-4cb3-95ae-f9c83eab8d31 61 fields · synced May 17, 2026
- EUDAMED 88a3e838-c2da-4da8-8fdb-f8fbe30c8d68 61 fields · synced May 18, 2026
- EUDAMED 0b76410e-3151-4ae9-85ce-4defb8c8eeef 61 fields · synced May 18, 2026
- EUDAMED c863bf87-0fc0-4976-9748-883b8dabb0d8 61 fields · synced May 18, 2026
- EUDAMED 99795f46-0762-4af3-9531-395b0be2a3da 61 fields · synced May 18, 2026
- EUDAMED 7f2cb81f-c7ad-470f-9b27-0bd2955b27ff 61 fields · synced May 18, 2026
- EUDAMED 0fc61fc6-3185-4d71-a2aa-4f8799de2bee 61 fields · synced May 18, 2026
- EUDAMED dc62ea38-2c0f-4671-a3c5-06221c5670b0 61 fields · synced May 18, 2026
- EUDAMED 99331522-d174-4c6d-8528-f5cca7f5db0d 61 fields · synced May 19, 2026
- EUDAMED 5f6285da-8ded-4888-868f-e88f5f46aaff 61 fields · synced Jun 18, 2026
- EUDAMED d208f57c-692d-4909-92a2-68bebaa2f6f7 61 fields · synced Jul 9, 2026
- EUDAMED 0100c68e-a736-404f-bf60-629f75f6ca51 61 fields · synced Jul 16, 2026
- EUDAMED e40bce30-9049-4a04-87bd-8816308dd922 61 fields · synced Jul 24, 2026
- EUDAMED 5c32c4c1-e156-4cad-8b0f-ad68ce458f46 61 fields · synced Aug 3, 2026