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Canule trachéale en silicone pur avec ballonnet basse pression et ligne d' aspi…
EUDAMEDClass IIb (EU MDR)
Ref 800-001-0986
Identity
- Trade Name
- Canule trachéale en silicone pur avec ballonnet basse pression et ligne d' aspiration EUDAMED
- Device Name
- All Silicone Tracheostomy Tube EUDAMED
- Model / Reference
- 800-001-0986 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04542187194296 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
Canule trachéale en silicone pur avec ballonnet basse pression et ligne d' aspi… by Create Medic Co., Ltd. — Class IIb — 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 | 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 (1)
- EUDAMED 6c78158a-ef39-46f6-8b8b-a8ff6871ec58 61 fields · synced Jun 17, 2026