← Back to catalogue
Leetrac
EUDAMEDClass I (EU MDR)
Ref LeetracModel LTNSSModel LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR
by B&L Biotech
Identity
- Trade Name
- Leetrac EUDAMED
- Device Name
- LEETRAC EUDAMED
- Model / Reference
- LTNSS EUDAMEDLeetrac EUDAMEDLTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019111009 EUDAMED
- Basic UDI-DI
- B-08800019111009 EUDAMED88000191LEETRACK4 EUDAMED
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Leetrac by B&L Biotech — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800019111009 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019111009 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 837dd4c5-b822-438e-833c-2760caca4aee 61 fields · synced Jul 12, 2026
- EUDAMED 1318c4b4-a7ae-4a7e-86fa-2df1fd2eacac 61 fields · synced Jun 14, 2026