Identity
- Trade Name
- Optimos™ Guidewire EUDAMED
- Device Name
- Optimos™ Guidewire EUDAMED
- Model / Reference
- GW3-45S EUDAMEDGW3-45A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809293839258 EUDAMED
- Basic UDI-DI
- 880923433-GW-CH EUDAMED
- EMDN Code
- G0399 DIGESTIVE ENDOSCOPY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
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
Optimos™ Guidewire by Taewoong Medical Co., Ltd. — Class IIa — 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 | 880923433-GW-CH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Taewoong Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000007515
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED c62823a7-635b-4749-9e8c-36c8dc136585 61 fields · synced May 22, 2026