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ULTRAMED ENDOTRACHEAL TUBE Preformed Oral Cuffed Size 8.5
EUDAMEDClass IIa (EU MDR)
Ref 4009-8.5/POModel ULTRAMED ENDOTRACHEAL TUBE Preformed Oral Cuffed Size 8.5Model ULTRAMED ENDOTRACHEAL TUBE Preformed Oral
Identity
- Trade Name
- ULTRAMED ENDOTRACHEAL TUBE Preformed Oral Cuffed Size 8.5 EUDAMED
- Device Name
- ULTRAMED ENDOTRACHEAL TUBE EUDAMED
- Model / Reference
- ULTRAMED ENDOTRACHEAL TUBE Preformed Oral Cuffed Size 8.5 EUDAMED4009-8.5/PO EUDAMEDULTRAMED ENDOTRACHEAL TUBE Preformed Oral EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06223004252778 EUDAMED
- Basic UDI-DI
- B-06223004252778 EUDAMED622300425ETT4010/PON7 EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Bulgaria 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: Basic endotracheal tube, single-use
ULTRAMED ENDOTRACHEAL TUBE Preformed Oral Cuffed Size 8.5 by Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) — Class IIa — MDR, MDD — listed in EUDAMED
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Also classified as Basic endotracheal tube, single-use.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06223004252778 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06223004252778 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000038562
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 004f724b-593d-43cd-b308-95a5ba9f3c8e 61 fields · synced Oct 6, 2026
- EUDAMED 7550439a-18f8-4386-a7e0-f47545762908 61 fields · synced May 19, 2026