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rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay)
EUDAMEDClass A (EU MDR)
Ref W050390
Identity
- Trade Name
- rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay) EUDAMED
- Device Name
- rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay) EUDAMED
- Model / Reference
- W050390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978918720058 EUDAMED
- Basic UDI-DI
- 697891872RCR001WF EUDAMED
- EMDN Code
- W0503900101 AGITATION RODS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay) by Xiamen Bioendo Technology Co., Ltd. — Class A — 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 | 697891872RCR001WF | Class A | Active |
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Manufacturer
- Manufacturer
- Xiamen Bioendo Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027676
- Authorised Representative
- JOYSUN GROUP S.L.U ES-AR-000043666
Sources (1)
- EUDAMED 903fe75a-2708-4927-abb9-1223c3c23c33 61 fields · synced Jul 11, 2026