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Pyrogen Test Kit (Monocyte Activation Test, MAT)
EUDAMEDClass A (EU MDR)
Ref W050390
Identity
- Trade Name
- Pyrogen Test Kit (Monocyte Activation Test, MAT) EUDAMED
- Device Name
- Pyrogen Test Kit (Monocyte Activation Test, MAT) EUDAMED
- Model / Reference
- W050390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 6978918720072 EUDAMED
- Basic UDI-DI
- 697891872MAT001U6 EUDAMED
- Direct Marketing DI
- 6978918720072 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
Yes
EUDAMED
Pyrogen Test Kit (Monocyte Activation Test, MAT) by Xiamen Bioendo 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 | 697891872MAT001U6 | 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 ab1a588b-e827-4e97-9b4a-641586d9ed02 61 fields · synced Jul 17, 2026