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JETIP Instruments
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel JEX, 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, TJIHGModel JICV
by B&L Biotech
Identity
- Trade Name
- JETIP Instruments EUDAMEDCastroviejo FDA UDI
- Generic Name
- Dental surgical scissors FDA UDI
- Device Name
- JETIP Instruments EUDAMED
- Model / Reference
- JEX, 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 EUDAMEDnone EUDAMEDJICV EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019115434 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191JINSTL5 EUDAMEDB-08800019115434 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental surgical scissors 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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 Instruments by B&L Biotech — Class I — 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 | 88000191JINSTL5 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000191JINSTL5 | 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 8d36410d-31e2-4326-9164-8a80cbb265c6 61 fields · synced Jul 10, 2026
- EUDAMED 1e8e2ffd-cd27-4e05-94d0-805a23a34546 61 fields · synced May 17, 2026
- FDA UDI 458d540b-2727-4f46-8898-1769180ecc17 32 fields · synced May 30, 2026
- EUDAMED 8d36410d-31e2-4326-9164-8a80cbb265c6-1 61 fields · synced Jun 10, 2026