← Back to catalogue
SP Connector, 22/15mm, 15M, 7.6F
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AC0062Model (P) Connector
Identity
- Trade Name
- SP Connector, 22/15mm, 15M, 7.6F EUDAMEDGaleMed FDA UDI
- Generic Name
- Tube/mask breathing circuit connector, single-use, sterile FDA UDI
- Device Name
- SP Connector EUDAMEDDisposable Straight Connector 15M,7.6F Port&Cap,22/15mm FDA UDI
- Model / Reference
- (P) Connector EUDAMEDAC0062 EUDAMED75311 FDA UDI
- Description
- Disposable Straight Connector 15M,7.6F Port&Cap,22/15mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710810082658 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNP188 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
SP Connector, 22/15mm, 15M, 7.6F 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 | 471081008NNP188 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED ea0c9ca9-7c5f-4ce6-87d9-885347661f6a 61 fields · synced Jun 18, 2026
- FDA UDI fa13dc19-f075-437e-8266-ae740be3ea76 34 fields · synced May 30, 2026