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T Connector, 10F, 4.3F, 10/7.6mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC0176Model (P) Connector
Identity
- Trade Name
- T Connector, 10F, 4.3F, 10/7.6mm EUDAMEDN/A FDA UDI
- Generic Name
- Nasopharyngeal airway, reusable FDA UDI
- Device Name
- T Connector EUDAMED
- Model / Reference
- (P) Connector EUDAMEDAC0176 EUDAMED75186 FDA UDI
Identifiers
- Catalog Number
- Neonate Tee Connector 10F,7.6F,4.3F FDA UDI
- Primary DI / UDI-DI
- 04710810114175 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNP28A EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Nasopharyngeal airway, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
T Connector, 10F, 4.3F, 10/7.6mm by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNP28A | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2325280d-39cb-437a-b855-928ef0380482 61 fields · synced Jul 12, 2026
- FDA UDI 9f2d6345-572a-4324-a2a3-04c820539647 34 fields · synced May 30, 2026