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SeqStudio™ Flex Dx series 96-Well Standard Retainer & Base Set
EUDAMEDClass A (EU MDR)
Ref A55961
Identity
- Trade Name
- SeqStudio™ Flex Dx series 96-Well Standard Retainer & Base Set EUDAMED
- Device Name
- 96 Well Standard Retainer and Base Set, a part of Genetic Analyzer Reagents and Consumables EUDAMED
- Model / Reference
- A55961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302015738 EUDAMED
- Basic UDI-DI
- 0190302A55961TF EUDAMED
- EMDN Code
- W02050185 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES 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
No
EUDAMED
New Device
No
EUDAMED
SeqStudio™ Flex Dx series 96-Well Standard Retainer & Base Set by Life Technologies Holdings Pte Ltd. — Class A — IVDR — listed in EUDAMED
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 | 0190302A55961TF | 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 ff5a008f-9c51-4fbb-bd5a-b768ed58d50d 61 fields · synced Jul 13, 2026