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Rurka intubacyjna z mankietem
EUDAMEDClass IIa (EU MDR)
Ref 11-8010
by SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa
Identity
- Trade Name
- Rurka intubacyjna z mankietem EUDAMED
- Device Name
- Rurka intubacyjna z mankietem EUDAMED
- Model / Reference
- 11-8010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05901292137427 EUDAMED
- Basic UDI-DI
- 59012921RIZMR9 EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa 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: Reinforced endotracheal tube, single-use
Rurka intubacyjna z mankietem by SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa — Class IIa — MDR — listed in EUDAMED
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Endotracheal Tube — Hangzhou Tappa Medical Technology Co , Ltd. · Class IIa
- Wire-Reinforced Endotracheal Tubes — Yushin Medical Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- Disposable Endotracheal Tube — Tianjin Plastics Research Institute Co., Ltd. · Class IIa
- RUSCH — TELEFLEX INCORPORATED · Class II
- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
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 | 59012921RIZMR9 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- PL-MF-000010592
Sources (1)
- EUDAMED 2dc4a4db-fa65-4672-a238-ca0b785d88a1 61 fields · synced Oct 6, 2026