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LineGene 9600 Plus Fluorescent Quantitative Detection System
EUDAMEDFDA UDIClass A (EU MDR)
Ref FQD-96A(EA2)Model FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6)
Identity
- Trade Name
- LineGene 9600 Plus Fluorescent Quantitative Detection System EUDAMEDBIOER LineGene 9600 Plus Fluorescent Quantitative Detection System FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- LineGene 9600 Plus Fluorescent Quantitative Detection System EUDAMEDFor the detail information, please refer to the IFU. FDA UDI
- Model / Reference
- FQD-96A(EA2), FQD-96A(EA4), FQD-96A(EA5), FQD-96A(EA6) EUDAMEDFQD-96A(EA2) EUDAMEDFDA UDI
- Description
- For the detail information, please refer to the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973843220765 EUDAMED06973843220529 FDA UDI
- Basic UDI-DI
- 697384322FQD004GW EUDAMED
- Direct Marketing DI
- 06973843220765 EUDAMED
- FDA Product Code
- OOI FDA UDI
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 862.2570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
LineGene 9600 Plus Fluorescent Quantitative Detection System by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322FQD004GW | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 773f8ab8-1116-49be-8d73-e5d3636c9b32 61 fields · synced Aug 1, 2026
- FDA UDI ecf1308f-e23a-489d-8d80-8b500bfe7869 33 fields · synced May 30, 2026