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Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format)
EUDAMEDClass A (EU MDR)
Ref Dx42800
Identity
- Device Name
- Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) EUDAMED
- Model / Reference
- Dx42800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G226DX428000+ EUDAMED
- Basic UDI-DI
- ++G226PlaSercfexRNAPKitCC EUDAMED
- Direct Marketing DI
- ++G226DX428000+ 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
- 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
Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format) by Norgen Biotek Corporation — Class A — IVDR — listed in EUDAMED
Manufacturer's product page: Exosomes
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 | ++G226PlaSercfexRNAPKitCC | Class A | Active |
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Manufacturer
- Manufacturer
- Norgen Biotek Corporation
- EUDAMED SRN
- CA-MF-000024034
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c29b36e6-8fe0-4a37-9ec2-4db3e382bfcd 61 fields · synced Jul 13, 2026