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Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster …
EUDAMEDClass A (EU MDR)
Ref Qilin Endomaster SeriesModel Qilin Endomaster
Identity
- Trade Name
- Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series) EUDAMED
- Device Name
- Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series) EUDAMED
- Model / Reference
- Qilin Endomaster EUDAMEDQilin Endomaster Series EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6978918720164 EUDAMED
- Basic UDI-DI
- 697891872QES001WX EUDAMED
- EMDN Code
- W0201030101 MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h) 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
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
Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster … 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 | 697891872QES001WX | 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 225c773f-107a-4f1c-a3b1-a10cea540c93 61 fields · synced Jun 18, 2026