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(1-3)-β-D-Glucan Detection Kit (Kinetic Chromogenic Method)
EUDAMEDClass B (EU MDR)
Ref KCG50Model 50 tests/kit、80 tests/kit、100 tests/kitRef KCG100
Identity
- Trade Name
- (1-3)-β-D-Glucan Detection Kit (Kinetic Chromogenic Method) EUDAMED
- Device Name
- (1-3)-β-D-Glucan Detection Kit (Kinetic Chromogenic Method) EUDAMED
- Model / Reference
- 50 tests/kit、80 tests/kit、100 tests/kit EUDAMEDKCG50 EUDAMEDKCG100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973106840006 EUDAMED06973106840648 EUDAMED
- Basic UDI-DI
- 697310684KCGQA EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
(1-3)-β-D-Glucan Detection Kit (Kinetic Chromogenic Method) by Xiamen Bioendo Technology Co., Ltd. — Class B — IVDR — listed in EUDAMED
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 | 697310684KCGQA | Class B | Active |
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Manufacturer
- Manufacturer
- Xiamen Bioendo Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027676
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 4dfa3de0-7ac9-48ef-9026-4951bba3858f 61 fields · synced Jul 9, 2026
- EUDAMED d47264bd-bffd-466a-9cad-f6464ba7ac1c 61 fields · synced May 18, 2026