Freeze-dried Six Respiratory Pathogens Nucleic Acid Detection Kit (Fluorescence PCR)
by Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. 5 variants
Ref HWTS-RT177CModel HWTS-RT177A
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697484936RT177AVK 06974849368703 | Date17 Jun 2026 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Model / Reference
- HWTS-RT177A, HWTS-RT177C
- Primary DI / UDI-DI
- 06974849368703
- Basic UDI-DI
- 697484936RT177AVK
- EMDN Code
- W0105070302 Other virus combinations - multiplex na reagents
- Device Class
- Class B
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000012807
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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Properties
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No