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DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0
EUDAMEDClass A (EU MDR)
Ref A25793
Identity
- Trade Name
- DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0 EUDAMED
- Device Name
- GeneScan Standard, a part of Genetic Analyzer Reagents and Consumables EUDAMED
- Model / Reference
- A25793 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190302007085 EUDAMED
- Basic UDI-DI
- 0190302A25793SH 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
Yes
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
DS-33 GeneScan™ Install Kit Dx with GeneScan™ 600 LIZ™ v2.0 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 | 0190302A25793SH | 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 394bf948-94ee-4a65-8a52-f9899bfe3d88 61 fields · synced Oct 7, 2026