Identity
- Device Name
- Urine DNA Isolation Kit Dx EUDAMED
- Model / Reference
- Dx48800 EUDAMED
Identifiers
- Primary DI / UDI-DI
- ++G226DX4880004 EUDAMED
- Basic UDI-DI
- ++G226UriDNAIsoKitX5 EUDAMED
- Direct Marketing DI
- ++G226DX4880004 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
Urine DNA Isolation 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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Manufacturer's product page: Milk DNA Preservation & Isolation
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 | ++G226UriDNAIsoKitX5 | 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 1cab236d-13c9-4359-acca-c4219e96feba 61 fields · synced Jul 22, 2026