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Canule trachéale en silicone pur avec ballonnet basse pression
EUDAMEDClass IIb (EU MDR)
Ref 800-001-2520Ref 800-001-2526Ref 800-001-2522Ref 800-001-0987Ref 800-001-2524Ref 800-001-0990Ref 800-001-0989Ref 800-001-0985Ref 800-001-1678Ref 800-001-2521Ref 800-001-0988
Identity
- Trade Name
- Canule trachéale en silicone pur avec ballonnet basse pression EUDAMEDCanule trachéale en silicone pur avec ballonnet basse pression et ligne d' aspiration EUDAMED
- Device Name
- All Silicone Tracheostomy Tube EUDAMED
- Model / Reference
- 800-001-2520 EUDAMED800-001-2526 EUDAMED800-001-2522 EUDAMED800-001-0987 EUDAMED800-001-2524 EUDAMED800-001-0990 EUDAMED800-001-0989 EUDAMED800-001-0985 EUDAMED800-001-1678 EUDAMED800-001-2521 EUDAMED800-001-0988 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187194364 EUDAMED04542187194425 EUDAMED04542187194388 EUDAMED04542187194302 EUDAMED04542187194401 EUDAMED04542187194357 EUDAMED04542187194340 EUDAMED04542187194289 EUDAMED04542187194319 EUDAMED04542187194371 EUDAMED04542187194326 EUDAMED
- Basic UDI-DI
- 45421870000995 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Canule trachéale en silicone pur avec ballonnet basse pression by Create Medic Co., Ltd. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
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- Trachealkanüle PRIMEDISTOM®, Gr.10, L = 85 mm — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Shiley — Covidien LP · Class II
- Trachealkanüle Ultrasoft Suction Gr.8 — Primed Halberstadt Medizintechnik GmbH · Class IIb
- Silber Innenkanüle mit Adaptionsring für rundes Kastenventil gesiebt — Theodor Labarre Werkstätte für silb. chirurg. Instrumente GmbH · Class IIb
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 | 45421870000995 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Create Medic Co., Ltd.
- EUDAMED SRN
- JP-MF-000010849
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (11)
- EUDAMED e221d806-4233-4f4e-9ef1-3953ae3e5e4a 61 fields · synced Jul 28, 2026
- EUDAMED ea324ce9-d728-4893-96ce-baaa56f39b6b 61 fields · synced May 17, 2026
- EUDAMED 102c8c99-e473-4f78-9c5a-089bbf055b76 61 fields · synced May 17, 2026
- EUDAMED 3928e408-c971-41b1-839e-13d7c9473a1c 61 fields · synced May 17, 2026
- EUDAMED 71819ed9-e071-4190-acaf-d71455f1a988 61 fields · synced May 17, 2026
- EUDAMED a42c7a48-081d-4a12-b625-0a2510fe32f7 61 fields · synced May 17, 2026
- EUDAMED fa970f6c-26a7-46d9-93d8-5fa27e2fa551 61 fields · synced May 18, 2026
- EUDAMED b045f777-31ce-4c7d-8706-94dac6327774 61 fields · synced May 18, 2026
- EUDAMED 5dfb1585-bc98-426a-9a23-227c1faa0562 61 fields · synced May 18, 2026
- EUDAMED b93f742b-4abf-49e7-bf5a-60e09bb003ac 61 fields · synced May 18, 2026
- EUDAMED 50f06346-88c3-48ab-acbe-4837e479f6b4 61 fields · synced May 18, 2026