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Optimos™ Guidewire
EUDAMEDClass IIa (EU MDR)
Ref GW3-45SRef GW3-26SRef GW2-45ARef GW2-26A
Identity
- Trade Name
- Optimos™ Guidewire EUDAMED
- Device Name
- Optimos™ Guidewire EUDAMED
- Model / Reference
- GW3-45S EUDAMEDGW3-26S EUDAMEDGW2-45A EUDAMEDGW2-26A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809293839234 EUDAMED08809293839241 EUDAMED08809293839364 EUDAMED08809293839371 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 (4)
- EUDAMED da8a2212-0c7c-4c2c-8b36-c97bab10ca78 61 fields · synced Oct 6, 2026
- EUDAMED 6fa0bdc3-1472-4042-958f-287ca370cbf4 61 fields · synced May 17, 2026
- EUDAMED 46de93c6-9afe-4854-b0bf-66ce2167d816 61 fields · synced May 17, 2026
- EUDAMED d1397728-640c-4ed3-9f54-f200f275ac14 61 fields · synced May 18, 2026