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Rurka tracheostomijna KAN bez mankietu
EUDAMEDClass IIb (EU MDR)
Ref 46-1014
by SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa
Identity
- Trade Name
- Rurka tracheostomijna KAN bez mankietu EUDAMED
- Device Name
- Rurka tracheostomijna bez mankietu EUDAMED
- Model / Reference
- 46-1014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901292142247 EUDAMED
- Basic UDI-DI
- 59012921RTBMQQ EUDAMED
- EMDN Code
- R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, NOT REINFORCED, WITH FIXED FLANGE, AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Rurka tracheostomijna KAN bez mankietu by SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa — Class IIb — MDR — listed in EUDAMED
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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 | 59012921RTBMQQ | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000010592
Sources (1)
- EUDAMED dc6db5b4-7c5b-44fb-8556-76effc30d396 61 fields · synced Jun 20, 2026