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Matrix for use with MALDI-TOF MS
EUDAMEDClass A (EU MDR)
Ref 2701200015Model Type II: 600 tests/boxRef 2701200017Model Type II 2500 tests/box
Identity
- Trade Name
- Matrix for use with MALDI-TOF MS EUDAMED
- Device Name
- Matrix for use with MALDI-TOF MS EUDAMED
- Model / Reference
- Type II: 600 tests/box EUDAMED2701200015 EUDAMEDType II 2500 tests/box EUDAMED2701200017 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971025210719 EUDAMED06971025210733 EUDAMED
- Basic UDI-DI
- 69710252106961116002MG EUDAMED69710252107331222003G8 EUDAMED
- Direct Marketing DI
- 06971025210719 EUDAMED06971025210733 EUDAMED
- EMDN Code
- W010499 MICROBIOLOGY TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMEDRomania 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
The Matrix for use with MALDI-TOF MS device is a laboratory instrument designed for protein detection and analysis. It uses matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF MS) to identify and quantify proteins in biological samples. This device provides accurate and reliable results, making it an essential tool for researchers, clinicians, and scientists.
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 | 69710252106961116002MG | Class A | Active |
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Manufacturer
- Manufacturer
- Zhuhai DL Biotech Co., Ltd.
- EUDAMED SRN
- CN-MF-000036485
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED d78e381f-d7d2-42b2-b011-0a2d3affdb0e 61 fields · synced Sep 17, 2026
- EUDAMED 39e56823-a0bc-4b74-b9b4-e7ba7e757869 61 fields · synced May 18, 2026