Identity
- Trade Name
- CAMERAS EUDAMEDProcam HD CMOS II FDA UDI
- Generic Name
- Surgical video camera FDA UDI
- Device Name
- PROCAM HD CMOS II EUDAMEDFDA UDI
- Model / Reference
- VI360/1 EUDAMEDR04 FDA UDI
- Description
- Procam HD CMOS II FDA UDI
Identifiers
- Catalog Number
- U1VI360 FDA UDI
- Primary DI / UDI-DI
- B366U1VI3601R04 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1PROCAMHDQ9 EUDAMED
- Direct Marketing DI
- B366U1VI3601R04 EUDAMED
- FDA Product Code
- FWD FDA UDI
- EMDN Code
- Z12020405 SURGICAL CAMERAS EUDAMED
- GMDN Term
- Surgical video camera FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4160 FDA UDI
- Market of Registration
- Greece 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
Cameras 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 | ++B366U1PROCAMHDQ9 | 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 28ad883c-34de-42a7-afcf-14de0e00392f 61 fields · synced Jun 18, 2026
- FDA UDI ff75273f-f7bb-4680-af9d-c6190e074f37 36 fields · synced May 30, 2026