Identity
- Trade Name
- Local Run Manager VeriSeq™ NIPT module EUDAMED
- Device Name
- Local Run Manager VeriSeq NIPT module EUDAMED
- Model / Reference
- 20044989 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816270020255 EUDAMED
- Basic UDI-DI
- 0081627002NIPTLRM95 EUDAMED
- EMDN Code
- W010699 GENETIC TESTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software 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
Local Run Manager VeriSeq™ NIPT module by Illumina, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0081627002NIPTLRM95 | Class A | Active |
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Manufacturer
- Manufacturer
- Illumina, Inc.
- EUDAMED SRN
- US-MF-000013476
- Authorised Representative
- Illumina Netherlands B.V. NL-AR-000012614
Sources (1)
- EUDAMED 88201140-9f29-4393-8d00-5b8bf500ba70 61 fields · synced Jun 17, 2026