Bite Gone
by Shenzhen Dongdixin Technology Co., Ltd. 3 variants
Ref CH3000 Type: Pro
Bite Gone (CH3000 Type: Pro) is a Class IIa device made by Shenzhen Dongdixin Technology Co., Ltd., registered in EUDAMED on 21 Apr 2023 (Basic UDI-DI 69264087CH001HT), active as of 7 Nov 2026.
Active
CE MDR
Valid until
20 Mar 2029
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69264087CH001HT 06926408711161 | Date21 Apr 2023 | StatusActive |
Official records
- EUDAMED public site 69264087CH001HT
Certificates
- FI23/0000008 Active
Quality management system EU MDR
- Certifier
- SGS FIMKO OY 0598
- Issued
- 12 Feb 2026
- Expires
- 20 Mar 2029
- FI23/0000008 Expired
Quality management system EU MDR
- Certifier
- SGS FIMKO OY 0598
- Issued
- 19 Dec 2025
- Expires
- 20 Mar 2026
- Valid from
- 20 Dec 2025
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- CH3000 Type: Pro
- Primary DI / UDI-DI
- 06926408711161
- Basic UDI-DI
- 69264087CH001HT
- EMDN code
- V9099 Various devices not included in other classes - other
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000009429
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
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