← Back to catalogue
Colposcope Hd
EUDAMEDFDA UDIClass I (EU MDR)
Ref MC410Model C-100FHD1Ref U1C100WModel C100A
Identity
- Trade Name
- COLPOSCOPE HD EUDAMEDCOLPOSCOPE EUDAMEDMICROSTAR Colposcope FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- COLPOSCOPE EUDAMEDColposcope w/ Wall Mount, Pantographic Arm & Inclined Binocular FDA UDIConsole Colposcope HD FDA UDI
- Model / Reference
- C-100FHD1 EUDAMEDMC410 EUDAMEDC100A EUDAMEDU1C100W EUDAMEDR00 FDA UDI
- Description
- Colposcope w/ Wall Mount, Pantographic Arm & Inclined Binocular FDA UDIConsole Colposcope HD FDA UDI
Identifiers
- Catalog Number
- U1C100W3 FDA UDIMC410 FDA UDI
- Primary DI / UDI-DI
- B366MC410 EUDAMEDFDA UDIB366U1C100W3R000 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1COLPOSCOPESHDA7 EUDAMED++B366U1COLPOSCOPESY9 EUDAMED
- Direct Marketing DI
- B366MC410 EUDAMEDB366U1C100W3R000 EUDAMED
- FDA Product Code
- HEX FDA UDI
- EMDN Code
- Z12020703 COLPOSCOPES EUDAMED
- GMDN Term
- Colposcope FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1630 FDA UDI
- Market of Registration
- Italy EUDAMEDFrance 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Colposcope Hd 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 | ++B366U1COLPOSCOPESHDA7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- EUSA Global Llc.
- EUDAMED SRN
- US-MF-000003607
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (4)
- EUDAMED a9842fa0-827f-493e-b225-a2cba2996567 61 fields · synced Jul 12, 2026
- FDA UDI 66d05c44-f841-41f8-bf22-88027658937a 36 fields · synced May 30, 2026
- FDA UDI a1cbed8e-9c5b-48f9-ae20-040167e0f04c 36 fields · synced May 30, 2026
- EUDAMED 14da349c-a43c-40ce-9423-ec031f9f12a3 61 fields · synced Jul 12, 2026