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Low-pass whole-genome aneuploidy Dx w1.0
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref A53848
Identity
- Trade Name
- Low-pass whole-genome aneuploidy Dx w1.0 EUDAMED
- Device Name
- Low-pass whole-genome aneuploidy Dx w1.0, a part of Ion Reporter (IR) Software Aneuploidy Dx Workflows EUDAMED
- Model / Reference
- A53848 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-USMF000023929A538488V EUDAMED
- Basic UDI-DI
- B-USMF000023929A538488V EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Special Device Type
- -1202 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
Low-pass whole-genome aneuploidy Dx w1.0 by Life Technologies Limited — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-USMF000023929A538488V | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Life Technologies Corporation
- EUDAMED SRN
- US-MF-000023929
- Authorised Representative
- Life Technologies Europe B.V. NL-AR-000021890
Sources (1)
- EUDAMED c9c85eae-785c-4f4c-8da1-5b7fd03b2a87 61 fields · synced Jul 10, 2026