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Connector, 10F, 10/7.6mm, K Resin
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC0042Model (P) Connector
Identity
- Trade Name
- Connector, 10F, 10/7.6mm, K Resin EUDAMEDGaleMed FDA UDI
- Generic Name
- Tube/mask breathing circuit connector, single-use, sterile FDA UDI
- Device Name
- Disp Connector EUDAMEDNeonate Straight Connector 10F , 10M/7.6F FDA UDI
- Model / Reference
- (P) Connector EUDAMEDAC0042 EUDAMED74007 FDA UDI
- Description
- Neonate Straight Connector 10F , 10M/7.6F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810114106 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNP98Q EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Tube/mask breathing circuit connector, single-use, sterile 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
Yes
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
No
FDA UDI
Connector, 10F, 10/7.6mm, K Resin 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 | 471081008NNP98Q | 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 47cefda1-97e8-4df8-b519-597027377326 61 fields · synced Jun 18, 2026
- FDA UDI 07289c1a-16da-4880-a83f-ec9d56c62609 34 fields · synced May 30, 2026