Identity
- Trade Name
- Colloidal Gold Immunoassay Analyzer EUDAMED
- Device Name
- Colloidal Gold Immunoassay Analyzer EUDAMED
- Model / Reference
- CG-300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06921963722973 EUDAMED
- Basic UDI-DI
- 692196372294JJ EUDAMED
- Direct Marketing DI
- 06921963722973 EUDAMED
- EMDN Code
- W0201069099 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Yes
EUDAMED
New Device
No
EUDAMED
Colloidal Gold Immunoassay Analyzer by Xiamen Boson Biotech Co., Ltd. — 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 | 692196372294JJ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000001096
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED fcb940ae-56ae-424f-80ad-b872f0ada4da 61 fields · synced Jul 8, 2026