Identity
- Trade Name
- TegadermTM IV Advanced Starter Kit 1683K EUDAMED
- Device Name
- Intravenous Starter Kit EUDAMED
- Model / Reference
- 1683K EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-1683KJ8 EUDAMED
- Basic UDI-DI
- B-1683KJ8 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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 Advanced Starter Kit 1683K by Itl Asia Pacific Sdn. Bhd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-1683KJ8 | 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 (1)
- EUDAMED 1d9ed069-d874-4c8c-9f2c-a3d28699800b 61 fields · synced Jul 9, 2026