← Back to catalogue
Is Tip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel STS-5A, STS-5EModel STS-5E
by B&L Biotech
Identity
- Trade Name
- IS TIP EUDAMEDFDA UDI
- Generic Name
- Dental implant/teeth debridement brush, biodegradable FDA UDI
- Device Name
- IS TIP EUDAMED
- Model / Reference
- STS-5A, STS-5E EUDAMEDnone EUDAMEDSTS-5E EUDAMEDSTS5E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110453 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191ISTIPMQ EUDAMEDB-08800019110453 EUDAMED
- FDA Product Code
- JET FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant/teeth debridement brush, biodegradable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6650 FDA UDI
- Market of Registration
- Denmark EUDAMEDPoland 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
Is 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 | 88000191ISTIPMQ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191ISTIPMQ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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 (4)
- EUDAMED ba32b054-c372-42ff-9756-fd197be1ee24 61 fields · synced Jun 20, 2026
- EUDAMED 2e6c22db-9f34-4bb0-813b-2d7c4168c228 61 fields · synced May 18, 2026
- FDA UDI 9297202b-09ae-4551-9d91-fca738a1ce4c 32 fields · synced May 30, 2026
- EUDAMED ba32b054-c372-42ff-9756-fd197be1ee24-1 61 fields · synced Jun 10, 2026