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Perfusion line for urodynamics with underpump segment Ø4, 00x6, 00mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref UD-A46215Model Pump lines/Urodynamic pump sets
Identity
- Trade Name
- Perfusion line for urodynamics with underpump segment Ø4,00x6,00mm EUDAMEDAtmos FDA UDI
- Generic Name
- Urological irrigation set FDA UDI
- Device Name
- Pump Tubing 4x6 mm FDA UDI
- Model / Reference
- Pump lines/Urodynamic pump sets EUDAMEDUD-A46215 EUDAMEDUD-46215 FDA UDI
- Description
- Pump Tubing 4x6 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08032248487123 EUDAMEDFDA UDI
- Basic UDI-DI
- 803224848701AL EUDAMED
- Direct Marketing DI
- 08032248487123 EUDAMED
- FDA Product Code
- EXQ FDA UDI
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Urological irrigation set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Perfusion line for urodynamics with underpump segment Ø4, 00x6, 00mm by Delta Med Spa — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 803224848701AL | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Delta Med SPA
- EUDAMED SRN
- IT-MF-000027962
Sources (2)
- EUDAMED 905a492c-7301-4899-a349-08fa147c45e6 61 fields · synced Jun 20, 2026
- FDA UDI 886525ab-fc7a-42f2-9bdc-2e0cda289e63 35 fields · synced May 30, 2026