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VeriSeq™ NIPT Sample Preparation Kit (96 samples)
EUDAMEDClass C (EU MDR)
Ref 15066802
Identity
- Trade Name
- VeriSeq™ NIPT Sample Preparation Kit (96 samples) EUDAMED
- Device Name
- VeriSeq™ NIPT Sample Preparation Kit EUDAMED
- Model / Reference
- 15066802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00816270020187 EUDAMED
- Basic UDI-DI
- 0081627002NIPTRP EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C 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
VeriSeq™ NIPT Sample Preparation Kit (96 samples) by Illumina, Inc. — Class C — 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 | 0081627002NIPTRP | Class C | 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 f2d1e0c9-3e5e-4ecb-97bb-06fe04ffcb7b 61 fields · synced Jul 9, 2026