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Any-Com Flow
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GB2206RC001Model 306 Any-Com Flow Kit, 306-1 ~ 306-17 Any-Com Flow Refill, 306-22 ~ 306-26 Any-Com Flow Rainbow, 309 Any-Com Flow Rainbow Kit
Identity
- Trade Name
- Any-Com Flow EUDAMED
- Device Name
- Any-Com Flow EUDAMED
- Model / Reference
- 306 Any-Com Flow Kit, 306-1 ~ 306-17 Any-Com Flow Refill, 306-22 ~ 306-26 Any-Com Flow Rainbow, 309 Any-Com Flow Rainbow Kit EUDAMEDGB2206RC001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518344178 EUDAMED
- Basic UDI-DI
- B-08809518344178 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Dental composite resin
Any-Com Flow by MEDICLUS Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
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 | K241147 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K250823 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809518344178 | 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 f1c5f709-c6d6-4537-8bf8-78ef817bb721 61 fields · synced Jun 19, 2026
- FDA 510(k) K241147 1 fields · synced May 18, 2026