Identity
- Trade Name
- NOVO Edera Opti H EUDAMED
- Model / Reference
- Kanülenhalteband EUDAMEDN15110030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260402643410 EUDAMED
- Basic UDI-DI
- 4260402642114X EUDAMED
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES 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
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
NOVO Edera Opti H by Novo Klinik-Service GmbH — Class I — 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 | 4260402642114X | Class I | Active |
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Manufacturer
- Manufacturer
- Novo Klinik-Service GmbH
- EUDAMED SRN
- DE-MF-000005289
Sources (1)
- EUDAMED 07b8f9b5-2466-4580-80d6-d73e6f7f801e 61 fields · synced Jul 9, 2026