Identity
- Trade Name
- Intravenous Start Kit EUDAMED
- Device Name
- IV Start Kit EUDAMED
- Model / Reference
- 061PC09146A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555240407061 EUDAMED
- Basic UDI-DI
- 955524040IVSPR EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class 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
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Intravenous Start Kit by Itl Asia Pacific Sdn. Bhd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 955524040IVSPR | Class I | Active |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-PR-000045529
Sources (1)
- EUDAMED fb88ca40-6d10-4d4a-82b6-f7cbaf8eef35 61 fields · synced Jun 19, 2026