Identity
- Trade Name
- Colposcope EUDAMED
- Device Name
- Colposcope EUDAMED
- Model / Reference
- MK-200 EUDAMEDMK-200-D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04820296530113 EUDAMED
- Basic UDI-DI
- 482029653MKUD EUDAMED
- EMDN Code
- Z12020703 COLPOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Colposcope by Science Engineering Center "Scaner" LLP — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 482029653MKUD | Class I | Active |
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Manufacturer
- Manufacturer
- Science Engineering Center "Scaner" LLP
- EUDAMED SRN
- UA-MF-000049340
- Authorised Representative
- AFINA, spol.s r.o. CZ-AR-000000584
Sources (1)
- EUDAMED d533d094-19c1-46e8-8696-7cbc965b87ca 61 fields · synced Jun 17, 2026