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Leetrac
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel LTRBSModel LTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR
by B&L Biotech
Identity
- Trade Name
- LEETRAC EUDAMEDLeetrac Wide Blade FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- LEETRAC EUDAMED
- Model / Reference
- LTRBS EUDAMEDFDA UDInone EUDAMEDLTRBS, LTRBT, LTRBR, LTSBS, LTNBS, LRTNH, LTSBR, LTNBP, LTNBN, LTNBT, LRNNH, LTNBR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019110866 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019110866 EUDAMED88000191LEETRACK4 EUDAMED
- FDA Product Code
- EMO FDA UDI
- EMDN Code
- L150201 DENTAL RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Periosteal elevator, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Leetrac by B&L Biotech — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800019110866 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019110866 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B&L Biotech
- EUDAMED SRN
- KR-MF-000023296
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED 56966761-ba85-448e-998b-67ae61dcae31 61 fields · synced Jul 9, 2026
- EUDAMED 26f0946d-9e4f-44f6-aca6-4d97cdb3d8be 61 fields · synced May 18, 2026
- FDA UDI 808beafa-b650-46f4-9573-2d68536bd448 32 fields · synced May 30, 2026
- EUDAMED 26f0946d-9e4f-44f6-aca6-4d97cdb3d8be-1 61 fields · synced Jun 10, 2026