Identity
- Trade Name
- Primeprint Tray 1.000 g EUDAMED
- Device Name
- Abdruckform, dental 3D EUDAMED
- Model / Reference
- 02838 / 6740216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET028381 EUDAMED
- Basic UDI-DI
- ++EDET0065J 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
Primeprint Tray 1.000 g by DETAX GmbH & Co. KG — 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European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDET0065J | Class I | No Longer Active |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (1)
- EUDAMED 755c23fb-3822-4e5c-90ce-a4dedf1ca2f4 61 fields · synced Jun 19, 2026