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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-AModel BL-5-EModel BL-1-AModel BL-1-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-A EUDAMEDBL-5-E EUDAMEDBL-1-A EUDAMEDBL-1-E EUDAMEDBL3A FDA UDIBL5E FDA UDIBL1E FDA UDIBL1A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110200 EUDAMEDFDA UDI08800019110224 EUDAMEDFDA UDI08800019110217 EUDAMEDFDA UDI08800019110255 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191BLTIPHS EUDAMEDB-08800019110224 EUDAMEDB-08800019110255 EUDAMEDB-08800019110200 EUDAMEDB-08800019110217 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 (16)
- EUDAMED 57adba97-173d-4d88-8ac9-c2a8b5f6f563 61 fields · synced Aug 4, 2026
- EUDAMED ed6768c9-8894-4f75-8e27-c48cc9007607 61 fields · synced May 17, 2026
- EUDAMED cebd613e-16b1-485e-b39f-0b8f8ec6d360 61 fields · synced May 17, 2026
- EUDAMED 834cabbf-dd6c-4f1e-acf6-7cd9ac459c73 61 fields · synced May 18, 2026
- EUDAMED d38e7d17-8d83-4ecb-bd87-688080149f80 61 fields · synced May 18, 2026
- EUDAMED b342b8dc-36e3-45ac-ac06-26e763f5aa4d 61 fields · synced May 18, 2026
- EUDAMED d4a87506-6854-4653-8414-32ffd33e38a8 61 fields · synced May 18, 2026
- EUDAMED 813b1ac2-9beb-43b6-82a6-f5728e09ebdc 61 fields · synced May 18, 2026
- FDA UDI 040e6dfc-43e3-4093-84bc-2fd7c0a56d9a 32 fields · synced May 29, 2026
- FDA UDI 2b07e214-dbda-482b-ac92-0f046dc7fa0f 32 fields · synced May 30, 2026
- FDA UDI 25bef760-979d-4595-9fd8-c33acb32a748 32 fields · synced May 30, 2026
- FDA UDI a170d88f-b3aa-41fd-a724-fea13616d9e7 32 fields · synced May 30, 2026
- EUDAMED cebd613e-16b1-485e-b39f-0b8f8ec6d360-1 61 fields · synced Jul 10, 2026
- EUDAMED b342b8dc-36e3-45ac-ac06-26e763f5aa4d-2 61 fields · synced Jul 19, 2026
- EUDAMED 57adba97-173d-4d88-8ac9-c2a8b5f6f563-1 61 fields · synced Jul 30, 2026
- EUDAMED d4a87506-6854-4653-8414-32ffd33e38a8-1 61 fields · synced Aug 4, 2026