Identity
- Trade Name
- Medical Microscope EUDAMEDFDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- Medical Microscope EUDAMED
- Model / Reference
- iX6,iX7,iX8 EUDAMEDiX8 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970873260181 EUDAMEDFDA UDI
- Basic UDI-DI
- 6970873260167BH EUDAMED
- Direct Marketing DI
- 06970873260181 EUDAMED
- FDA Product Code
- FSO FDA UDI
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES EUDAMED
- GMDN Term
- General-purpose surgical microscope FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4700 FDA UDI
- Market of Registration
- Germany 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Medical Microscope by Denjoy Dental Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6970873260167BH | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Denjoy Dental Co., Ltd
- EUDAMED SRN
- CN-MF-000044157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED eff520dc-0289-494f-80bd-886ba2529f90 61 fields · synced Jul 28, 2026
- FDA UDI 20bd97cd-d64f-41c0-869e-5ce9361a68ad 32 fields · synced May 30, 2026