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Reusable guide
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref GPK-490Model Reusable guide510(k) K141334
by Koelis
Identity
- Trade Name
- Reusable guide EUDAMED
- Model / Reference
- Reusable guide EUDAMEDGPK-490 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03665134000790 EUDAMED
- Basic UDI-DI
- 3665134GPK_01UR EUDAMED
- Direct Marketing DI
- 03665134000790 EUDAMED
- EMDN Code
- Z11049080 VARIOUS ULTRASOUND INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Reusable guide by Koelis — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141334 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 3665134GPK_01UR | Class I | Active |
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Manufacturer
- Manufacturer
- Koelis
- EUDAMED SRN
- FR-MF-000000830
Sources (2)
- EUDAMED 5fb9bc97-e387-46f9-accb-b40ec482ed53 85 fields · synced Jun 19, 2026
- FDA 510(k) K141334 1 fields · synced May 18, 2026