Identity
- Trade Name
- BISI-TRAY EUDAMED
- Model / Reference
- Light curing tray material EUDAMED03250 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D93232501- EUDAMED
- Basic UDI-DI
- ++D932LoeMStandardPS EUDAMED
- Direct Marketing DI
- +D93232501- EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I 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 impression tray, single-use
Bisi-Tray by dent a pharm Produktionsgesellschaft mbH — 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 | ++D932LoeMStandardPS | Class I | Active |
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Manufacturer
- Manufacturer
- Dent-A-Pharm Produktionsgesellschaft mbH
- EUDAMED SRN
- DE-MF-000012922
Sources (1)
- EUDAMED 6528c52a-8252-4505-ac11-bf1a7c94ac3e 61 fields · synced Jul 21, 2026