Identity
- Device Name
- Disconnect Wedge 15mm NS + 25/BX EUDAMED
- Model / Reference
- 011-DWG300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15019517382846 EUDAMED
- Basic UDI-DI
- 0610586M0158DG EUDAMED
- Direct Marketing DI
- 15019517382846 EUDAMED
- EMDN Code
- R01058099 TRACHEOSTOMY AND LARYNGECTOMY CANNULAS - VARIOUS ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Disconnect Wedge 15mm NS + 25/BX by Icu Medical, Inc. — 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 | 0610586M0158DG | Class I | Active |
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Manufacturer
- Manufacturer
- ICU Medical, Inc.
- EUDAMED SRN
- US-MF-000009764
- Authorised Representative
- ICU Medical BV NL-AR-000002748
Sources (1)
- EUDAMED 59bb4be2-d791-450f-9fe7-507f1ddc8517 61 fields · synced Jul 18, 2026