Identity
- Trade Name
- COLPOSCREEN EUDAMED
- Device Name
- VIDEOCOLPOSCOPE EUDAMED
- Model / Reference
- 19657001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08436041581499 EUDAMED
- Basic UDI-DI
- 84360415801152K EUDAMED
- EMDN Code
- Z1202070801 VIDEO COLPOSCOPY SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Colposcreen by Optomic España S.a — 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 | 84360415801152K | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Optomic España S.a
- EUDAMED SRN
- ES-MF-000003235
Sources (1)
- EUDAMED a267aa66-6746-482f-ab85-8ee50e59fc7b 61 fields · synced Jul 15, 2026