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Paediatric TegadermTM IV Starter Kit 1610K
EUDAMEDClass IIa (EU MDR)
Ref 1610KRef 061PC09122A
Identity
- Trade Name
- Paediatric TegadermTM IV Starter Kit 1610K EUDAMEDIV Starter Kit - Paediatric EUDAMED
- Device Name
- Intravenous Starter Kit EUDAMEDIV Start Kit EUDAMED
- Model / Reference
- 1610K EUDAMED061PC09122A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1610KGU EUDAMED09555240407016 EUDAMED
- Basic UDI-DI
- B-1610KGU 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
Paediatric TegadermTM IV Starter Kit 1610K by Itl Asia Pacific Sdn. Bhd. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ophthalmic surgical procedure kit, non-medicated, single-use.
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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-1610KGU | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-1610KGU | 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 (2)
- EUDAMED 51a4b7ed-e053-4aa1-99f5-42503830c2f4 61 fields · synced Oct 5, 2026
- EUDAMED 20b97d32-44b2-444e-b559-80f743297d08 61 fields · synced Jul 20, 2026