Identity
- Trade Name
- pink mix 8 x 50ml EUDAMED
- Device Name
- Ohr-Abdruckmaterial, Silikongummi EUDAMED
- Model / Reference
- 03913 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET039131 EUDAMED
- Basic UDI-DI
- ++EDET0185R 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
pink mix 8 x 50ml 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European Union No Longer Active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| EUDAMED | European Union | CE/MDR | ++EDET0185R | Class IIa | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (1)
- EUDAMED fc21284d-64d9-4d01-b9f5-9661fc2bb45b 61 fields · synced May 22, 2026