Identity
- Trade Name
- Colloidal Gold Reader EUDAMED
- Device Name
- Colloidal Gold Reader EUDAMED
- Model / Reference
- GIA100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974404980043 EUDAMED
- Basic UDI-DI
- 697440498gia3A EUDAMED
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
Classification
- Device Class
- Class A 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 Reader by Shenzhen Kang Sheng Bao Bio-Technology 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 | 697440498gia3A | Class A | Active |
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Manufacturer
- Manufacturer
- Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000024153
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 63b35fe2-a0d0-4d60-acf0-d817be96613c 61 fields · synced Oct 6, 2026