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Canule trachéale en silicone pur à ballonnet plaqué
EUDAMEDClass IIb (EU MDR)
Ref 12-2137Ref 12-2126Ref 12-2122
Identity
- Trade Name
- Canule trachéale en silicone pur à ballonnet plaqué EUDAMED
- Device Name
- All Silicone Tracheostomy Tube EUDAMED
- Model / Reference
- 12-2137 EUDAMED12-2126 EUDAMED12-2122 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187147636 EUDAMED04542187147605 EUDAMED04542187147599 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 à ballonnet plaqué 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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- 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 (3)
- EUDAMED bfcb22a7-669d-4e0b-89e4-1a6e3e43fd9d 61 fields · synced Jul 13, 2026
- EUDAMED 8922a276-475f-418d-9a04-7c0888cdfc35 61 fields · synced May 18, 2026
- EUDAMED 6cbc32da-ef65-48dd-867a-0f3bec8d2878 61 fields · synced May 19, 2026