Identity
- Trade Name
- bioplast 40 shore 8 x 50 ml EUDAMED
- Device Name
- Silikonmaterial zur Herstellung von Otoplastiken EUDAMED
- Model / Reference
- 02081 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET020811 EUDAMED
- Basic UDI-DI
- ++EDET0245L 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
bioplast 40 shore 8 x 50 ml 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European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDET0245L | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (1)
- EUDAMED 4cc4553f-2e9b-4c1e-aa05-06ad7126afce 61 fields · synced Oct 6, 2026