← Back to catalogue
LineGene Mini Fluorescent Quantitative Detection System
EUDAMEDClass A (EU MDR)
Ref FQD-16A(EA4)Model FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4)Ref FQD-16A(EA2H)Ref FQD-16A(EA2R)
Identity
- Trade Name
- LineGene Mini Fluorescent Quantitative Detection System EUDAMED
- Device Name
- LineGene Mini Fluorescent Quantitative Detection System EUDAMED
- Model / Reference
- FQD-16A(EA2R), FQD-16A(EA2H), FQD-16A(EA4) EUDAMEDFQD-16A(EA4) EUDAMEDFQD-16A(EA2H) EUDAMEDFQD-16A(EA2R) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843221236 EUDAMED06973843221229 EUDAMED06973843221212 EUDAMED
- Basic UDI-DI
- 697384322FQD001GQ EUDAMED
- Direct Marketing DI
- 06973843221236 EUDAMED06973843221229 EUDAMED06973843221212 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 Mini Fluorescent Quantitative Detection System by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED
Similar devices
Also classified as Nucleic acid sample preparation instrument IVD.
- Applied Biosystems™ SeqStudio™ 24 Flex Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- TANBead Nucleic Acid Extractor — Taiwan Advanced Nanotech Inc. · Class A
- NC-15Plus(32) — HANWOOLTPC Co., Ltd. · Class A
- 3500 Dx Genetic Analyzer — Life Technologies Holdings Pte Ltd. · Class A
- ALLSHENG — HANGZHOU ALLSHENG INSTRUMENTS CO., LTD. · Class I
- isoQuarkM4 — RevoSketch Inc. · Class A
- Automated Nucleic Acid Extraction and Amplification System — Hybribio Medtech Device Co.,Ltd · Class A
- Real-time PCR system — Hangzhou Bio-gener Technology Co., Ltd. · Class A
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 | 697384322FQD001GQ | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED 8cdd4539-aa30-45fb-86f0-32092a73ed0c 61 fields · synced Jul 23, 2026
- EUDAMED 1f637846-083c-4cb6-b56c-a1e1c49cfab4 61 fields · synced May 18, 2026
- EUDAMED 3d098586-3c70-4876-a14c-ccdce27fbf01 61 fields · synced May 19, 2026