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JETIP Instruments Micro Mirror
EUDAMEDFDA UDIClass I (EU MDR)
Ref noneModel JIMM1,JIMM2,JIMM3,JIMMH
by B&L Biotech
Identity
- Trade Name
- JETIP Instruments Micro Mirror EUDAMEDMicro Mirror Handle FDA UDI
- Generic Name
- Dental mirror, reusable FDA UDI
- Device Name
- JETIP Instuments Micro Mirror EUDAMEDJIMMH EUDAMED
- Model / Reference
- JIMM1,JIMM2,JIMM3,JIMMH EUDAMEDnone EUDAMEDJIMMH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800019115472 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000191JIMMMG EUDAMEDB-08800019115472 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
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 Micro Mirror 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 | 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 f4f8e4a2-3714-4ab7-a0ef-64f6c39c00eb 61 fields · synced Jul 29, 2026
- EUDAMED d6e443b5-5fa5-4702-b2b3-089b471d2535 61 fields · synced May 17, 2026
- FDA UDI 50a797e0-731c-433d-920a-35f88f17b538 32 fields · synced May 30, 2026
- EUDAMED f4f8e4a2-3714-4ab7-a0ef-64f6c39c00eb-1 61 fields · synced Jun 10, 2026