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Once-Fil Flow
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GB2021OC006(092021)Model OF1GBS5S-B, OF1GBS5S-Y, 101-1 Once-Fil Flow Blue, 101-2 Once-Fil Flow Yellow
Identity
- Trade Name
- Once-Fil Flow EUDAMED
- Device Name
- Once-Fil Flow EUDAMED
- Model / Reference
- OF1GBS5S-B, OF1GBS5S-Y, 101-1 Once-Fil Flow Blue, 101-2 Once-Fil Flow Yellow EUDAMEDGB2021OC006(092021) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518340651 EUDAMED
- Basic UDI-DI
- B-08809518340651 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Once-Fil Flow by MEDICLUS Co., Ltd. — Class IIa — FDA_510K, MDD — 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/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251283 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809518340651 | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEDICLUS Co., Ltd.
- EUDAMED SRN
- KR-MF-000022584
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 537ca512-5447-4324-8e7b-50e1dcc76a92 61 fields · synced Jun 18, 2026
- FDA 510(k) K251283 1 fields · synced May 18, 2026