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TegadermTM IV Starter Kit 1633K
EUDAMEDClass IIa (EU MDR)
Ref 1633KRef 061PC09124ARef 061PC09123A
Identity
- Trade Name
- TegadermTM IV Starter Kit 1633K EUDAMEDIV Starter Kit EUDAMED
- Device Name
- Intravenous Starter Kit EUDAMEDIV Start Kit EUDAMED
- Model / Reference
- 1633K EUDAMED061PC09124A EUDAMED061PC09123A EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1633KHF EUDAMED09555240406743 EUDAMED09555240406736 EUDAMED
- Basic UDI-DI
- B-1633KHF 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
TegadermTM IV Starter Kit 1633K 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-1633KHF | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-1633KHF | 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 (3)
- EUDAMED 1f415c0c-c6f0-47d1-8dc7-f115bb32ecc2 61 fields · synced Jul 31, 2026
- EUDAMED 16e2c527-69f4-4278-9cbe-b4a7c8bd6003 61 fields · synced Jul 12, 2026
- EUDAMED 0d57dfda-bf11-43c6-89e6-a79ba79d7cd8 61 fields · synced Jul 14, 2026