JETIP Instruments
EUDAMEDFDA UDIClass I (EU MDR)
by B&L Biotech
Identity
- Trade Name
- JETIP Instruments EUDAMEDFDA UDI
- Generic Name
- Dental material application tool, reusable FDA UDI
- Device Name
- JETIP Instruments EUDAMED
- Model / Reference
- JM3 EUDAMEDFDA UDInone EUDAMEDJEX, JE1, JC4, JC3, JC9, JX2, JE2, JE4, JC1, JX1, JPP, JC2, JE3, JC12, JM3, JC10, JM2, JC13, JC16, JC15, JC11, JM1, JM4, JC14, JP6, JP2, JP8, JP7, JB2, JP3, JP9, JIHB, JIHY, JIHS, TJIHS, JIHG, TJIHY, TJIHB, TJIHG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800019115243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800019115243 EUDAMED88000191JINSTL5 EUDAMED
- FDA Product Code
- EMJ FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental material application tool, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The JETIP Instruments medical device, developed by B&L Biotech, is a Class I device that offers precise measurements for various applications. Its versatility and accuracy make it an essential tool in medical research, diagnostics, and treatment.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800019115243 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800019115243 | 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 4d6778a6-b3f1-490b-be2a-fbd39fbb414c 61 fields · synced Sep 17, 2026
- EUDAMED c6364bf3-cf0b-40ec-9638-363185ef647e 61 fields · synced May 18, 2026
- FDA UDI b35c957d-cc53-4e0d-ba06-17ada082fc71 32 fields · synced May 29, 2026
- EUDAMED c6364bf3-cf0b-40ec-9638-363185ef647e-1 61 fields · synced Jun 9, 2026