Identity
- Trade Name
- Demi Pro EUDAMED
- Device Name
- LED Light Curing System EUDAMED
- Model / Reference
- Demi Pro EUDAMED37382 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809455602607 EUDAMED
- Basic UDI-DI
- 880945560009KH EUDAMED
- Direct Marketing DI
- 08809455602607 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 — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 77cc4c44-8588-497f-b28e-c5f93e4f6d38 61 fields · synced Jun 18, 2026