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Inner Cannula Cleaning Swab for UniPerc Adjustable Flange Tracheostomy Tube, 5/…
EUDAMEDClass I (EU MDR)
Ref 011-100/892/200CZ
Identity
- Device Name
- Inner Cannula Cleaning Swab for UniPerc Adjustable Flange Tracheostomy Tube, 5/EA EUDAMED
- Model / Reference
- 011-100/892/200CZ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15019517382860 EUDAMED
- Basic UDI-DI
- 0610586M0301CV EUDAMED
- Direct Marketing DI
- 15019517382860 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
Inner Cannula Cleaning Swab for UniPerc Adjustable Flange Tracheostomy Tube, 5/… by Icu Medical, Inc. — Class I — MDR — listed in EUDAMED
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 | 0610586M0301CV | 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 aa04d799-ff0e-42a6-8e56-1c5470f4b6c5 61 fields · synced Oct 6, 2026