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Connecting line Male luer lock - Female luer lock
EUDAMEDFDA UDIClass I (EU MDR)
Ref UD-AELNModel Rectal and/or urethral catheter extensions
Identity
- Trade Name
- Connecting line Male luer lock - Female luer lock EUDAMEDAtmos FDA UDI
- Generic Name
- Urological pressure monitoring tubing set FDA UDI
- Device Name
- Transparent Extension Line 1500mm FDA UDI
- Model / Reference
- Rectal and/or urethral catheter extensions EUDAMEDUD-AELN EUDAMEDFDA UDI
- Description
- Transparent Extension Line 1500mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032248490130 EUDAMEDFDA UDI
- Basic UDI-DI
- 8032248490019Q EUDAMED
- Direct Marketing DI
- 08032248490130 EUDAMED
- FDA Product Code
- EXQ FDA UDI
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Urological pressure monitoring tubing set FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 1500 Millimeter FDA UDI
Connecting line Male luer lock - Female luer lock by Delta Med Spa — Class I — 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 | 8032248490019Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (2)
- EUDAMED 29188546-3608-415b-9ba9-5b6a3d3822d4 61 fields · synced Jul 12, 2026
- FDA UDI 2ef87c46-28bf-4665-b21c-fdc4191c2dc8 35 fields · synced May 30, 2026