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Microscopes & Accessories
EUDAMEDFDA UDIClass I (EU MDR)
Ref VI202/2Model U1VI2021
Identity
- Trade Name
- MICROSCOPES & ACCESSORIES EUDAMEDPROCAM HD 2D FDA UDI
- Generic Name
- General-purpose surgical microscope FDA UDI
- Device Name
- PROCAM HD 2D EUDAMEDFDA UDI
- Model / Reference
- U1VI2021 EUDAMEDVI202/2 EUDAMEDR00 FDA UDI
- Description
- PROCAM HD 2D FDA UDI
Identifiers
- Catalog Number
- U1VI2022 FDA UDI
- Primary DI / UDI-DI
- B366U1VI2022R00 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1PROCAMHD2DXF EUDAMED
- Direct Marketing DI
- B366U1VI2022R00 EUDAMED
- FDA Product Code
- HRM FDA UDI
- EMDN Code
- Z1201118099 INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER 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
- Romania 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
Yes
FDA UDI
Microscopes & Accessories by EUSA Global Llc. — 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 | ++B366U1PROCAMHD2DXF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 4be84773-0897-44ef-a87f-bb50f990e6ee 61 fields · synced Jun 18, 2026
- FDA UDI 3bb5bcba-2378-4e88-b7ea-7ea3e8a8991f 36 fields · synced May 25, 2026