Identity
- Trade Name
- Otex Express EUDAMED
- Device Name
- Otex Express EUDAMED
- Model / Reference
- 100083 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016379299001 EUDAMED
- Basic UDI-DI
- B-05016379299001 EUDAMED
- EMDN Code
- Q030499 OTOLOGY DEVICES - OTHER 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Otex Express by Diomed Developments Limited — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05016379299001 | Class I | Active |
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Manufacturer
- Manufacturer
- Diomed Developments Limited
- EUDAMED SRN
- GB-MF-000004862
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED b7a358df-4197-478a-922f-2317518aeaaa 61 fields · synced Jul 8, 2026