← Back to catalogue
CentriDx Automated Nucleic Acid Analyzer
EUDAMEDClass A (EU MDR)
Ref CentriDx 200(EA4)Model CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6)Ref CentriDx 200(EA5)
Identity
- Trade Name
- CentriDx Automated Nucleic Acid Analyzer EUDAMED
- Device Name
- CentriDx Automated Nucleic Acid Analyzer EUDAMED
- Model / Reference
- CentriDx 200(EA4) , CentriDx 200(EA5) , CentriDx 200(EA6) EUDAMEDCentriDx 200(EA4) EUDAMEDCentriDx 200(EA5) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843221175 EUDAMED06973843221182 EUDAMED
- Basic UDI-DI
- 697384322FQD012GV EUDAMED
- Direct Marketing DI
- 06973843221175 EUDAMED06973843221182 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
CentriDx Automated Nucleic Acid Analyzer by Hangzhou Bioer Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 697384322FQD012GV | 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 (2)
- EUDAMED e93ba598-885f-4832-a5b0-57ab238a9509 61 fields · synced Jul 17, 2026
- EUDAMED f6ee2f51-6454-4cbf-b3bc-9a2ae4a28bd3 61 fields · synced May 17, 2026