← Back to catalogue
luxaprint 3D shell 385 beige 500 g
EUDAMEDClass IIa (EU MDR)
Ref 03538Model Colour variants
by DETAX GmbH
Identity
- Trade Name
- luxaprint 3D shell 385 beige 500 g EUDAMED
- Model / Reference
- Colour variants EUDAMED03538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET035381 EUDAMED
- Basic UDI-DI
- ++EDET0815Y EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER 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
luxaprint 3D shell 385 beige 500 g by DETAX GmbH & Co. KG — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++EDET0815Y | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DETAX GmbH
- EUDAMED SRN
- DE-MF-000022666
Sources (1)
- EUDAMED 0e6decbd-5645-4f93-a788-2799f5c046b6 61 fields · synced Jul 30, 2026