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Demi Pro
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 37381Model Demi ProRef 37384Ref 37385Ref 37383Ref 37387
Identity
- Trade Name
- Demi Pro EUDAMED
- Device Name
- LED Light Curing System EUDAMED
- Model / Reference
- Demi Pro EUDAMED37381 EUDAMED37384 EUDAMED37385 EUDAMED37383 EUDAMED37387 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809455602591 EUDAMED08809455602621 EUDAMED08809455602638 EUDAMED08809455602614 EUDAMED08809455602652 EUDAMED
- Basic UDI-DI
- 880945560009KH EUDAMED
- Direct Marketing DI
- 08809455602591 EUDAMED08809455602652 EUDAMED
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Category: Dental appliance fabrication material, ceramic
Demi Pro by Meta Systems Co., Ltd. — Class I — FDA_510K, MDR — 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/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253461 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 880945560009KH | Class I | Active |
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Manufacturer
- Manufacturer
- Meta Systems Co., Ltd.
- EUDAMED SRN
- KR-MF-000022945
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (6)
- EUDAMED dbe92745-46e9-4e3d-ba8f-00a7bd27c524 61 fields · synced Jul 29, 2026
- EUDAMED c33d91af-42e2-4da0-b406-0daf331af653 61 fields · synced May 17, 2026
- EUDAMED e75a7bd2-2d80-4827-ae5c-d5b495293aa6 61 fields · synced May 17, 2026
- EUDAMED f113b9b6-4c5a-403a-b90a-1b8ca9e6fa37 61 fields · synced May 18, 2026
- EUDAMED 96551b95-4a1c-4216-9129-3de6f8485ea9 61 fields · synced May 19, 2026
- FDA 510(k) K253461 1 fields · synced May 18, 2026