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Jetip
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref noneModel JT-2L-A, JT-2R-E, JT-2B-E, JT-2L-E, JT-2R-A, JT-2S-A, JT-2B-A, JT-2S-EModel JT-2R-E
by B&L Biotech
Identity
- Trade Name
- JETIP EUDAMEDFDA UDI
- Generic Name
- Dental ultrasonic surgical system FDA UDI
- Device Name
- JETIP EUDAMED
- Model / Reference
- JT-2L-A, JT-2R-E, JT-2B-E, JT-2L-E, JT-2R-A, JT-2S-A, JT-2B-A, JT-2S-E EUDAMEDnone EUDAMEDJT-2R-E EUDAMEDJT2RE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019110354 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191JETIPJZ EUDAMEDB-08800019110354 EUDAMED
- FDA Product Code
- JET FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Dental ultrasonic surgical system 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
Jetip 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 | 88000191JETIPJZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88000191JETIPJZ | 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 (4)
- EUDAMED 3eb2b8c3-18de-4208-a6ed-d853f2ebe095 61 fields · synced Jul 17, 2026
- EUDAMED 3246ee21-d8fb-4550-84bf-51e654781944 61 fields · synced May 17, 2026
- FDA UDI 05828ffc-f3fb-470f-b849-63187b9364bc 32 fields · synced May 30, 2026
- EUDAMED 3eb2b8c3-18de-4208-a6ed-d853f2ebe095-1 61 fields · synced Jun 10, 2026