Identity
- Trade Name
- COLPOSCOPE EUDAMEDMICROSCOPE Colposcope FDA UDI
- Generic Name
- Colposcope FDA UDI
- Device Name
- COLPOSCOPE EUDAMEDColposcope w/ Floor Telescopic Stand FDA UDI
- Model / Reference
- C-200A EUDAMEDR01 FDA UDI
- Description
- Colposcope w/ Floor Telescopic Stand FDA UDI
Identifiers
- Catalog Number
- U1C200A FDA UDI
- Primary DI / UDI-DI
- B366U1C200AR01 EUDAMEDFDA UDI
- Basic UDI-DI
- ++B366MICROSTARC200CP EUDAMED
- Direct Marketing DI
- B366U1C200AR01 EUDAMED
- 510(k) Number
- K100595 FDA UDI
- 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
Colposcope 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 | ++B366MICROSTARC200CP | 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 547bddc1-2b67-44de-ad26-6fb1e184753e 61 fields · synced Jul 8, 2026
- FDA UDI 4573ec00-77d7-482f-a23c-7e86cb32f355 37 fields · synced May 30, 2026