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Bl Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel BL-1-A, BL-1-E BL-3-A, BL-3-E BL-5-A, BL-5-EModel BL-3-E
by B&L Biotech
Identity
- Trade Name
- BL TIP EUDAMEDFDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
- Device Name
- BL TIP EUDAMED
- Model / Reference
- BL-1-A, BL-1-E BL-3-A, BL-3-E BL-5-A, BL-5-E EUDAMEDnone EUDAMEDBL-3-E EUDAMEDBL3E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110231 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191BLTIPHS EUDAMEDB-08800019110231 EUDAMED
- FDA Product Code
- JET FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system handpiece tip, endodontic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6650 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
No
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
Bl Tip by B&L Biotech — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 88000191BLTIPHS | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191BLTIPHS | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (3)
- EUDAMED f9e76abd-c82a-4fe8-a1d9-a9cab258c722 61 fields · synced Aug 3, 2026
- EUDAMED bd1be389-489e-4b89-a85b-0d86f5852f60 61 fields · synced May 17, 2026
- FDA UDI a763e664-e713-4247-adba-5c1d1dc2d5d4 32 fields · synced May 30, 2026