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Fast Real-time Fluorescence PCR Analyzer
EUDAMEDClass A (EU MDR)
Ref BTK-1Model BTK-8, BTK-1
Identity
- Device Name
- Fast Real-time Fluorescence PCR Analyzer EUDAMED
- Model / Reference
- BTK-8, BTK-1 EUDAMEDBTK-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974541565219 EUDAMED
- Basic UDI-DI
- 697454156006L5 EUDAMED
- EMDN Code
- W02050301 NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Fast Real-time Fluorescence PCR Analyzer by Bioteke Corporation (Wuxi) 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 | 697454156006L5 | Class A | Active |
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Manufacturer
- Manufacturer
- BioTeke Corporation（Wuxi）Co., Ltd
- EUDAMED SRN
- CN-MF-000007517
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED ea6dad55-6e67-43e5-b893-b7b28e4adbdb 61 fields · synced Jul 31, 2026