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protoCEM Dual Cure Adhesive Resin Cement
EUDAMEDClass IIa (EU MDR)
Ref -Model Metacem TL
Identity
- Trade Name
- protoCEM Dual Cure Adhesive Resin Cement EUDAMED
- Device Name
- Dual Cure Adhesive Resin Cement EUDAMED
- Model / Reference
- Metacem TL EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08806387861140 EUDAMED
- Basic UDI-DI
- B-08806387861140 EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
protoCEM Dual Cure Adhesive Resin Cement by Meta Biomed Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08806387861140 | 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 edfded8f-07ac-4caa-bd5b-927446ef0feb 61 fields · synced Jul 12, 2026