← Back to catalogue
Immunoglobulin G (IgG) Kit(Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref 01.09.03.08.EC.01
by Zybio Inc.
Identity
- Device Name
- Immunoglobulin G (IgG) Kit(Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 01.09.03.08.EC.01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941967223139 EUDAMED
- Basic UDI-DI
- B-06941967223139 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
No
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
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
Immunoglobulin G (IgG) Kit(Immunoturbidimetric Method) by Zybio Inc. — Class IVD General — IVDD — 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
- IGG — Medicon Hellas SA · Class B
- 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
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06941967223139 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zybio Inc.
- EUDAMED SRN
- CN-MF-000003349
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED eade0952-2a56-4822-8b7d-8748a8a5415c 61 fields · synced Jul 13, 2026