Urine Nucleic Acid Collection and Preservation System Dx
by Norgen Biotek Corporation EUDAMED
Active
Ref Dx76200
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number++G226UrineNACPDevJC | Date8 Oct 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Urine Nucleic Acid Collection and Preservation System Dx
- Model / Reference
- Dx76200
- Primary DI / UDI-DI
- ++G226UrineNACPDevQC
- Basic UDI-DI
- ++G226UrineNACPDevJC
- EMDN Code
- W05010202 Urine collection, tubes
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CA-MF-000024034
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
From the manufacturer
Manufacturer's product page: Urine
Other devices from Norgen Biotek Corporation
Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No