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Plasma/Serum Cell-Free Circulating Purification Kit Dx
EUDAMEDClass A (EU MDR)
Ref Dx55500Ref Dx55100Ref Dx55600
Identity
- Device Name
- Plasma/Serum Cell-Free Circulating Purification Kit Dx EUDAMED
- Model / Reference
- Dx55500 EUDAMEDDx55100 EUDAMEDDx55600 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G226DX555000% EUDAMED++G226DX551000_ EUDAMED++G226DX5560000 EUDAMED
- Basic UDI-DI
- ++G226PlaSercfcDNAPKitXA EUDAMED
- Direct Marketing DI
- ++G226DX555000% EUDAMED++G226DX551000_ EUDAMED++G226DX5560000 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
Category: Nucleic acid extraction/isolation kit IVD
Plasma/Serum Cell-Free Circulating Purification Kit Dx by Norgen Biotek Corporation — 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
Manufacturer's product page: RNA
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 | ++G226PlaSercfcDNAPKitXA | 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 (3)
- EUDAMED 7a5c3a61-1a2e-4e7f-b1f7-573f5b28ec87 61 fields · synced Jul 29, 2026
- EUDAMED 57182649-5b5e-4842-88b5-3c1f4c3c58d4 61 fields · synced May 17, 2026
- EUDAMED 16660d28-360c-4af5-8e97-0ad55f6f1512 61 fields · synced May 18, 2026