Identity
- Trade Name
- smartrepair rosa EUDAMED
- Device Name
- smartrepair EUDAMED
- Model / Reference
- 03364 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET033641 EUDAMED
- Basic UDI-DI
- ++EDET0285U EUDAMED
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS 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
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, resin
smartrepair rosa by DETAX GmbH & Co. KG — Class IIa — 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 | ++EDET0285U | Class IIa | Active |
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Manufacturer
- Manufacturer
- DETAX GmbH
- EUDAMED SRN
- DE-MF-000022666
Sources (1)
- EUDAMED 37dc1535-3e43-4ac8-a6a3-59f271974691 61 fields · synced Oct 6, 2026