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Real-Time Quantitative PCR System
EUDAMEDClass A (EU MDR)
Ref PCR111601Model X-poche16Model X-Poche 16
Identity
- Trade Name
- Real-Time Quantitative PCR System EUDAMED
- Device Name
- Real-Time Quantitative PCR System EUDAMED
- Model / Reference
- X-poche16 EUDAMEDPCR111601 EUDAMEDX-Poche 16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974323018049 EUDAMED06979502241478 EUDAMED
- Basic UDI-DI
- 697432301YQ003FH EUDAMED697950224PCR1116016E EUDAMED
- EMDN Code
- W02010399 INTEGRATED / MODULAR CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER EUDAMEDW02050116 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
Real-Time Quantitative PCR System by Beijing Applied Biological Technologies 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 | 697432301YQ003FH | 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 136066da-7ea9-48e2-bbf6-50cb3e502574 61 fields · synced Jul 12, 2026
- EUDAMED 666a0abb-0bf2-4a97-af8f-a4e8a2d93713 61 fields · synced Jul 12, 2026