Saliva Collection Kit
by Jiangsu HanHeng Medical Technology Co., Ltd. China EUDAMED
Ref HH-10-B4Model HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B8
EMDN W05019002
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697369781215RD | Date23 Apr 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Saliva Collection Kit
- Model / Reference
- HH-5-B2、HH-5-B3、HH-10-B2、HH-10-B3、HH-10-B4、HH-10-B5、HH-10-B6、HH-10-B8, HH-10-B4
- Primary DI / UDI-DI
- 06973697812192
- Basic UDI-DI
- 697369781215RD
- EMDN Code
- W05019002 Saliva collection devices
- Device Class
- Class A
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- CN-MF-000023013
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
Other devices from Jiangsu HanHeng Medical Technology Co., Ltd
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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 21c36e7b-1da8-4da4-8843-92eb5af5be07