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Colpoitpro
EUDAMEDClass I (EU MDR)
Ref ASITSWB2FK4K6Model COLPOITPRO COLPOSCOPY IMAGING SOFTWARE
Identity
- Trade Name
- COLPOITPRO EUDAMED
- Device Name
- COLPOITPRO COLPOSCOPY IMAGING SOFTWARE EUDAMED
- Model / Reference
- COLPOITPRO COLPOSCOPY IMAGING SOFTWARE EUDAMEDASITSWB2FK4K6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020602247 EUDAMED
- Basic UDI-DI
- 8908020602COV24D54 EUDAMED
- Direct Marketing DI
- 08908020602247 EUDAMED
- EMDN Code
- Z12020492 INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Romania 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
Colpoitpro by AmbalSoft InfoTech Private Limited — 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 | 8908020602COV24D54 | Class I | Active |
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Manufacturer
- Manufacturer
- AmbalSoft InfoTech Private Limited
- EUDAMED SRN
- IN-MF-000029308
- Authorised Representative
- Amstermed B.V. NL-AR-000001971
Sources (1)
- EUDAMED e83ec414-044e-4efd-b022-ab4edceaa609 61 fields · synced Jun 17, 2026