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Trachea Tee Set, w/Tubing
EUDAMEDClass IIa (EU MDR)
Ref AO0058Model (H) Ventilation Circuit
Identity
- Trade Name
- Trachea Tee Set, w/Tubing EUDAMED
- Device Name
- Catheter Mount EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAO0058 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810083976 EUDAMED
- Basic UDI-DI
- 471081008NNH77U EUDAMED
- EMDN Code
- R02010199 STANDARD BREATHING CIRCUITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Trachea Tee Set, w/Tubing by GaleMed Corporation — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 471081008NNH77U | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 777b1a67-f0fc-487d-a9c9-05562ea6999b 61 fields · synced Jul 27, 2026