JETIP Instruments Micro Mirror
EUDAMEDFDA UDIClass I (EU MDR)
by B&L Biotech
Identity
- Trade Name
- JETIP Instruments Micro Mirror EUDAMEDMicro Mirror FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- JETIP Instuments Micro Mirror EUDAMEDJIMM2 EUDAMED
- Model / Reference
- JIMM1,JIMM2,JIMM3,JIMMH EUDAMEDnone EUDAMEDJIMM2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019115458 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191JIMMMG EUDAMEDB-08800019115458 EUDAMED
- FDA Product Code
- EAX FDA UDI
- EMDN Code
- L160201 DENTAL MIRRORS AND HANDLES, REUSABLE EUDAMED
- GMDN Term
- Dental mirror, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Poland 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 Micro Mirror is a cutting-edge medical device designed for endoscopic applications. It features advanced micro-mirrors that allow for precise visualization and dissection of tissue, making it an ideal tool for various surgical procedures.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 88000191JIMMMG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 88000191JIMMMG | 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 ce23fce7-49ad-43ba-bb36-77521b80013c 61 fields · synced Jul 19, 2026
- EUDAMED 92987c54-e26e-4d3b-b6de-770255e86deb 61 fields · synced May 19, 2026
- FDA UDI ef2ba03f-1fa5-4131-97ac-a8a07f5d09fb 32 fields · synced May 29, 2026
- EUDAMED ce23fce7-49ad-43ba-bb36-77521b80013c-1 61 fields · synced Jun 10, 2026