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Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer
EUDAMEDClass A (EU MDR)
Ref A50534
Identity
- Trade Name
- Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer EUDAMED
- Device Name
- Applied Biosystems™ SeqStudio™ Flex Dx Series Genetic Analyzer EUDAMED
- Model / Reference
- A50534 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302018838 EUDAMED
- Basic UDI-DI
- 0190302A50534RM EUDAMED
- EMDN Code
- W02050116 NUCLEIC ACID TESTING INTEGRATED EXTRACTION /AMPLIFICATION /DETECTION SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands 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
Applied Biosystems™ SeqStudio™ 8 Flex Dx Genetic Analyzer by Life Technologies Holdings Pte 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 | 0190302A50534RM | Class A | Active |
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Manufacturer
- Manufacturer
- Life Technologies Holdings Pte Ltd
- EUDAMED SRN
- SG-MF-000023931
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED 22819c02-c560-4448-970e-16338f456528 61 fields · synced Jun 19, 2026