Leetrac
Part of a family of 16 devices: see the family page
Ref LeetracModel LTNSS, LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR
Leetrac is a medical device (EU MDD Class I; EMDN category dental retractors) made by B&L Biotech, registered in EUDAMED on 19 May 2026 (Basic UDI-DI B-08800019111009), active as of 22 Oct 2026.
Active
CE MDD
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08800019111009 08800019111009 | Date19 May 2026 | StatusActive |
Official records
- EUDAMED public site B-08800019111009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Model / reference
- LTNSS, Leetrac, LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR
- Primary DI / UDI-DI
- 08800019111009
- Basic UDI-DI
- B-08800019111009, 88000191LEETRACK4
- EMDN code
- L150201 Dental retractors, reusable
- Device class
- Class I
- EU registration type
- Legacy device (under a directive)Standard device
- EU market of registration
- Denmark
Manufacturer details
- EUDAMED SRN
- KR-MF-000023296
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
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