Identity
- Trade Name
- HD COLPOSCOPE HEAD EUDAMEDMICROSTAR Colposcope FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- COLPOSCOPE EUDAMEDHD Colposcope Head FDA UDI
- Model / Reference
- C-100FHD1 EUDAMEDMC400 EUDAMEDR02 FDA UDI
- Description
- HD Colposcope Head FDA UDI
Identifiers
- Catalog Number
- MC400 FDA UDI
- Primary DI / UDI-DI
- B366MC400 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366U1COLPOSCOPESHDA7 EUDAMED
- Direct Marketing DI
- B366MC400 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 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
Hd Colposcope Head 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 |
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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 f96d476f-d65a-4670-849a-8e437b88569b 61 fields · synced Jun 18, 2026
- FDA UDI 80154cb2-f2c4-44ae-b0fe-b5d51a1ba828 36 fields · synced May 29, 2026