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Automatic Nucleic Acid Extraction and Real-Time PCR System
EUDAMEDClass A (EU MDR)
Ref MP112401Model ABT-24
Identity
- Trade Name
- Automatic Nucleic Acid Extraction and Real-Time PCR System EUDAMED
- Device Name
- Automatic Nucleic Acid Extraction and Real-Time PCR System EUDAMED
- Model / Reference
- ABT-24 EUDAMEDMP112401 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018025 EUDAMED06979502241485 EUDAMED
- Basic UDI-DI
- 697432301YQ002FF EUDAMED697950224MP112401MV EUDAMED
- Direct Marketing DI
- 06974323018025 EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany 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
Category: Nucleic acid sample preparation instrument IVD
Automatic Nucleic Acid Extraction and Real-Time PCR System by Beijing Applied Biological Technologies Co., Ltd. — Class A — IVDR — listed in EUDAMED
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Also classified as Nucleic acid sample preparation instrument IVD.
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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 | 697432301YQ002FF | Class A | Active |
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Manufacturer
- Manufacturer
- Beijing Applied Biological Technologies Co., Ltd.
- EUDAMED SRN
- CN-MF-000012338
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 56d9d548-9edc-467e-ab29-a24772dd430a 61 fields · synced Jul 13, 2026
- EUDAMED e48eee89-8173-422f-a557-ac16d787f991 61 fields · synced Jul 13, 2026