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rFC Endotoxin Test Kit (Recombinant Factor C Fluorometric Assay)
EUDAMEDClass A (EU MDR)
Ref RFC001
Identity
- Trade Name
- rFC Endotoxin Test Kit (Recombinant Factor C Fluorometric Assay) EUDAMED
- Device Name
- This device is not currently linked with any other devices. EUDAMED
- Model / Reference
- RFC001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6978918720065 EUDAMED
- Basic UDI-DI
- 697891872RFC001U7 EUDAMED
- Direct Marketing DI
- 6978918720065 EUDAMED
- EMDN Code
- W0503900101 AGITATION RODS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
rFC Endotoxin Test Kit (Recombinant Factor C Fluorometric 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 | 697891872RFC001U7 | 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 5044401b-c6d0-4d9e-8a9d-c858cccc173f 61 fields · synced Jun 18, 2026