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Veracyte FFPE RNA Extraction Kit
EUDAMEDClass A (EU MDR)
Ref 550100
by Veracyte SAS
Identity
- Device Name
- Veracyte FFPE RNA Extraction Kit EUDAMED
- Model / Reference
- 550100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760366720093 EUDAMED
- Basic UDI-DI
- 376036672EXFFPEGS EUDAMED
- EMDN Code
- W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Ireland 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
Category: Nucleic acid extraction/isolation kit IVD
Veracyte FFPE RNA Extraction Kit by Veracyte SAS — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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- MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 376036672EXFFPEGS | Class A | No Longer Active |
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Manufacturer
- Manufacturer
- Veracyte SAS
- EUDAMED SRN
- FR-MF-000024879
Sources (1)
- EUDAMED e06fe2b2-ec49-4f77-9480-97e827363dba 61 fields · synced Jul 17, 2026