Identity
- Trade Name
- K3 EDTA + Gel EUDAMED
- Device Name
- VACUUM TUBES EUDAMED
- Model / Reference
- K3EG1307502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08606034792175 EUDAMED
- Basic UDI-DI
- 8606110811-BLOOD-TUBE-JV EUDAMED
- Direct Marketing DI
- 08606034792175 EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Croatia EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
K3 EDTA + Gel by Hygienx Doo Beograd-Rakovica — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8606110811-BLOOD-TUBE-JV | Class A | Active |
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Manufacturer
- Manufacturer
- Hygienx Doo Beograd-Rakovica
- EUDAMED SRN
- RS-MF-000048020
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED 5a235e77-be7e-4ec8-9956-b5f125095288 61 fields · synced Jul 29, 2026