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Colpoitpro
EUDAMEDClass I (EU MDR)
Ref ASITKTB2FK4K6Model COLPOITPRO COLPOSCOPY IMAGING SOFTWARERef ASITKTB2HDDE4Ref ASITKTB2SDDI2Ref ASITSWB2SDLE1Ref ASITKTB2HDEX3Ref ASITKTB2SDLE1Ref ASITSWB2TD3D7Ref ASITSWB23D4K9Ref ASITSWB2HDEX3
Identity
- Trade Name
- COLPOITPRO EUDAMED
- Device Name
- COLPOITPRO COLPOSCOPY IMAGING SOFTWARE EUDAMED
- Model / Reference
- COLPOITPRO COLPOSCOPY IMAGING SOFTWARE EUDAMEDASITKTB2FK4K6 EUDAMEDASITKTB2HDDE4 EUDAMEDASITKTB2SDDI2 EUDAMEDASITSWB2SDLE1 EUDAMEDASITKTB2HDEX3 EUDAMEDASITKTB2SDLE1 EUDAMEDASITSWB2TD3D7 EUDAMEDASITSWB23D4K9 EUDAMEDASITSWB2HDEX3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08908020602148 EUDAMED08908020602155 EUDAMED08908020602162 EUDAMED08908020602193 EUDAMED08908020602179 EUDAMED08908020602186 EUDAMED08908020602254 EUDAMED08908020602278 EUDAMED08908020602216 EUDAMED
- Basic UDI-DI
- 8908020602COV24D54 EUDAMED
- Direct Marketing DI
- 08908020602148 EUDAMED08908020602155 EUDAMED08908020602162 EUDAMED08908020602193 EUDAMED08908020602179 EUDAMED08908020602186 EUDAMED08908020602254 EUDAMED08908020602278 EUDAMED08908020602216 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 (9)
- EUDAMED b391e592-b047-4269-bc92-29ab977886db 61 fields · synced Jul 24, 2026
- EUDAMED cb361404-e5a8-46e9-b9ed-07d283db0572 61 fields · synced May 16, 2026
- EUDAMED 7f8e4aed-4301-4e2f-9089-7b0db19a7856 61 fields · synced May 17, 2026
- EUDAMED 02466fcc-d0da-4267-ba72-90dd5b67bd7a 61 fields · synced May 17, 2026
- EUDAMED 9531510a-029b-40ed-9ebb-9cad7ad45aa5 61 fields · synced May 18, 2026
- EUDAMED 66d6f6c5-3e78-4dea-a304-29783534be38 61 fields · synced May 18, 2026
- EUDAMED e1ed1a2e-1f14-4268-9c0e-6a590ee1ef5d 61 fields · synced May 18, 2026
- EUDAMED 5bf471ba-b4fc-4313-be68-25f1ace72464 61 fields · synced May 18, 2026
- EUDAMED 52ec0c52-f166-41bc-b177-4c6669225724 61 fields · synced May 19, 2026