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Stool Nucleic Acid Collection and Preservation Devices Dx
EUDAMEDClass A (EU MDR)
Ref Dx45660
Identity
- Device Name
- Stool Nucleic Acid Collection and Preservation Devices Dx EUDAMED
- Model / Reference
- Dx45660 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G226DX4566016 EUDAMED
- Basic UDI-DI
- ++G226StoolNACPDevUA EUDAMED
- Direct Marketing DI
- +G226DX4563608 EUDAMED
- EMDN Code
- W05019001 FAECES COLLECTION DEVICES 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
No
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Stool Nucleic Acid Collection and Preservation Devices Dx by Norgen Biotek Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: Collection & Preservation
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 | ++G226StoolNACPDevUA | 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 1b2cabdd-5069-4dee-894c-101afbfe18f9 61 fields · synced Jun 17, 2026