Identity
- Trade Name
- IGG EUDAMED
- Device Name
- IGG EUDAMED
- Model / Reference
- 1419-0790 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309123117 EUDAMED
- Basic UDI-DI
- 5204309000030NK EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Igg by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD.
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- PRESTIGE 24i IgG — PZ CORMAY Spółka Akcyjna · IVD General
- Horizon — BECTON DICKINSON AND COMPANY · Class I
- Immunoglobulin G Assay Kit (Immunoturbidimetric Method) — Da Te Bioengineering Technology Co., LTD. · IVD General
- A-400 IgG — PZ CORMAY Spółka Akcyjna · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Tissue-Tek Genie® — Sakura Finetek USA, Inc · Class I
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 | 5204309000030NK | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (1)
- EUDAMED caaf88e1-f52a-45a8-832f-232ec27a2c7e 61 fields · synced Jun 18, 2026