Identity
- Trade Name
- OTOCIL 30 sh 1 kg EUDAMED
- Device Name
- Ohr-Abdruckmaterial, Silikongummi EUDAMED
- Model / Reference
- 02114 / SICI301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET021141 EUDAMED
- Basic UDI-DI
- ++EDET0185R EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
OTOCIL 30 sh 1 kg 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European Union No Longer Active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| EUDAMED | European Union | CE/MDR | ++EDET0185R | Class IIa | No Longer Active |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (1)
- EUDAMED 0ade9d08-23f9-4d9d-9cad-1eafba1511f4 61 fields · synced Jun 19, 2026