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L Connector, 4.3M, 4M
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC0113Model (P) Connector
Identity
- Trade Name
- L Connector, 4.3M, 4M EUDAMEDN/A FDA UDI
- Generic Name
- Nasopharyngeal airway, reusable FDA UDI
- Device Name
- L Connector EUDAMED
- Model / Reference
- (P) Connector EUDAMEDAC0113 EUDAMED72224 FDA UDI
Identifiers
- Catalog Number
- Neonate Elbow Connector 4.3M, 4.0M FDA UDI
- Primary DI / UDI-DI
- 04710810088919 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNP58G 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
L Connector, 4.3M, 4M 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 | 471081008NNP58G | 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 41bf1008-1241-41cf-9eda-7762d0957043 61 fields · synced Jun 18, 2026
- FDA UDI 3ac20988-f6bf-4051-ac07-2f16282d5728 34 fields · synced May 30, 2026