Silicone tip
by Hangzhou Weize Imp & Exp Co., Ltd. 8 variants
Part of a family of 14 devices: see the family page
Ref HG-ST08Model HG-ST01,HG-ST02,HG-ST03,HG-ST04,HG-ST05,HG-ST06,HG-ST07,HG-ST08,HG-ST09,HG-ST10
Silicone tip (HG-ST08) is a Class I device made by Hangzhou Weize Imp & Exp Co., Ltd., registered in EUDAMED on 28 May 2026 (Basic UDI-DI 697654367SiliconetipLS), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697654367SiliconetipLS 06976543671479 | Date28 May 2026 | StatusActive |
Official records
- EUDAMED public site 697654367SiliconetipLS
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- Withdrawn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/MDR Active
Specification
- Device name
- Silicone tip
- Model / reference
- HG-ST01, HG-ST02, HG-ST03, HG-ST04, HG-ST05, HG-ST06, HG-ST07, HG-ST08, HG-ST09, HG-ST10
- Primary DI / UDI-DI
- 06976543671479
- Basic UDI-DI
- 697654367SiliconetipLS
- EMDN code
- Q030199 Nasopharyngeal devices - other
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- CN-MF-000036544
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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