HPV Screen Sampling Kits
by Jiangsu HanHeng Medical Technology Co., Ltd. China EUDAMED
Ref HPV-D-8Model HPV-D-2, HPV-D-3, HPV-D-5, HPV-D-8, HPV-D-10, HPV-D-12
EMDN W05019099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697369781828SL | Date3 Jun 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- HPV Screen Sampling Kits
- Model / Reference
- HPV-D-2, HPV-D-3, HPV-D-5, HPV-D-8, HPV-D-10, HPV-D-12
- Primary DI / UDI-DI
- 06973697818316
- Basic UDI-DI
- 697369781828SL
- EMDN Code
- W05019099 Samples collection devices - other
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023013
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED 657bd312-94b0-4d8c-b086-d6eb81785d85