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Any-Core
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref GB2021OC005(012022)Model 801-1 Any-Core A3, 802-1 Any-Core White, 803-1 Any-Core Blue, 801-2 Any-Core Refill A3, 802-2 Any-Core Refill White, 803-2 Any-Core Refill Blue
Identity
- Trade Name
- Any-Core EUDAMED
- Device Name
- Any-Core EUDAMED
- Model / Reference
- 801-1 Any-Core A3, 802-1 Any-Core White, 803-1 Any-Core Blue, 801-2 Any-Core Refill A3, 802-2 Any-Core Refill White, 803-2 Any-Core Refill Blue EUDAMEDGB2021OC005(012022) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809518342150 EUDAMED
- Basic UDI-DI
- B-08809518342150 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER 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 appliance fabrication material, ceramic
Any-Core 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
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252465 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809518342150 | 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 76694ae7-b1b2-44f9-89f2-f5452818213a 61 fields · synced Jul 15, 2026
- FDA 510(k) K252465 1 fields · synced May 18, 2026