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LineGene K Plus Fluorescent Quantitative Detection System
EUDAMEDClass A (EU MDR)
Ref FQD-48A(EA4)Model FQD-48A(EA2), FQD-48A(EA4)Ref FQD-48A(EA2)
Identity
- Trade Name
- LineGene K Plus Fluorescent Quantitative Detection System EUDAMED
- Device Name
- LineGene K Plus Fluorescent Quantitative Detection System EUDAMED
- Model / Reference
- FQD-48A(EA2), FQD-48A(EA4) EUDAMEDFQD-48A(EA4) EUDAMEDFQD-48A(EA2) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843221250 EUDAMED06973843221243 EUDAMED
- Basic UDI-DI
- 697384322FQD003GU EUDAMED
- Direct Marketing DI
- 06973843221250 EUDAMED06973843221243 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
LineGene K Plus Fluorescent Quantitative Detection System by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
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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 | 697384322FQD003GU | Class A | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED d8d6245b-6d1e-431b-b388-2958738722d4 61 fields · synced Jul 15, 2026
- EUDAMED 14bc7385-ad3e-4fb4-8193-b6221d19d7ad 61 fields · synced May 19, 2026