Saliva Collection Kit
by Jiangsu HanHeng Medical Technology Co., Ltd. 11 variants
Ref HH-10Model HH-5、HH-10、HH-5-A2、HH-5-A3、HH-10-A2、HH-10-A3、HH-10-A4、HH-10-A5、HH-10-A6、HH-10-A8
Active
CE IVDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number697369781205RA 06973697812086 | Date23 Apr 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Saliva Collection Kit
- Model / Reference
- HH-5、HH-10、HH-5-A2、HH-5-A3、HH-10-A2、HH-10-A3、HH-10-A4、HH-10-A5、HH-10-A6、HH-10-A8, HH-10
- Primary DI / UDI-DI
- 06973697812086
- Basic UDI-DI
- 697369781205RA
- EMDN Code
- W05019002 Saliva collection devices
- Device Class
- Class A
- EU 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
See all devices from Jiangsu HanHeng Medical Technology Co., Ltd →
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