Identity
- Trade Name
- 4K3D Video Microscope EUDAMED4K3D Video Microscope HawkSight FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- 4K3D Video Microscope HawkSight EUDAMED
- Model / Reference
- HawkSight EUDAMEDHS EUDAMEDKV3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04589698450602 EUDAMEDFDA UDI
- Basic UDI-DI
- 458969845060Q6 EUDAMED
- Direct Marketing DI
- 04589698450602 EUDAMED
- FDA Product Code
- EPT 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
- Czechia 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
4K3D Video Microscope by Mitaka Kohki 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 | 458969845060Q6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mitaka Kohki Co., Ltd.
- EUDAMED SRN
- JP-MF-000013028
- Authorised Representative
- Mitaka Europe GmbH DE-AR-000006361
Sources (2)
- EUDAMED d74d21d1-7a4a-453b-9f09-69c89b74f6ee 61 fields · synced Jul 20, 2026
- FDA UDI 144df274-eb17-4f4e-b69f-3a8608e5e888 32 fields · synced May 30, 2026