Identity
- Trade Name
- Scopeye 3D Addon EUDAMED
- Device Name
- Scopeye 3D Addon EUDAMED
- Model / Reference
- SE-AO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 88001826004164 EUDAMED
- Basic UDI-DI
- 88001826SEAOQZ EUDAMED
- EMDN Code
- Z12011101 OPERATIVE MICROSCOPES 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
Scopeye 3D Addon by MediThinQ Co., Ltd. — 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 | 88001826SEAOQZ | Class I | Active |
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Manufacturer
- Manufacturer
- MediThinQ. Co., Ltd.
- EUDAMED SRN
- KR-MF-000021424
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 25861054-3bac-42e4-b63f-2f224aad1ab5 61 fields · synced Jun 17, 2026