Identity
- Trade Name
- Mega Temp EUDAMED
- Device Name
- Hydraulic Temporary Restorative Material EUDAMED
- Model / Reference
- MD-Temp Plus White EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806387860631 EUDAMED
- Basic UDI-DI
- B-08806387860631 EUDAMED
- EMDN Code
- Q0101010203 TEMPORARY DENTAL CEMENTS 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
Mega Temp by Meta Biomed Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08806387860631 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Meta Biomed Co., Ltd.
- EUDAMED SRN
- KR-MF-000009681
- Authorised Representative
- Meta Biomed Europe GmbH DE-AR-000004953
Sources (1)
- EUDAMED 671abb1a-4571-4752-be14-3aaf1aa9ff67 61 fields · synced Jun 19, 2026