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Sterile Endo-tracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref AN021006Model With cuff
Identity
- Trade Name
- Sterile Endo-tracheal Tube EUDAMED
- Device Name
- Sterile Endo-tracheal Tube EUDAMED
- Model / Reference
- With cuff EUDAMEDAN021006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09341601000763 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSET001NK EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile Endo-tracheal Tube by Multigate Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697201396MU2ASNNNSET001NK | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED 67dd2ff2-3c09-4dd5-9da6-b705636b61c6 61 fields · synced Jun 19, 2026