Dual Lumen CMG/UPP Catheter 7F
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Dual Lumen Catheter 7F EUDAMEDFDA UDIDual Lumen CMG/UPP Catheter 7F FDA UDI
- Generic Name
- Urodynamic manometric catheter, non-electronic FDA UDI
- Device Name
- 2-lumen Catheter for Cystometry and Urethral EUDAMED
- Model / Reference
- DLC-7D EUDAMEDFDA UDI9021P5062 EUDAMEDDLUPP-7D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825000222 EUDAMEDFDA UDI00627825000277 FDA UDI
- Basic UDI-DI
- 062782501N9 EUDAMED
- FDA Product Code
- FEN FDA UDI
- EMDN Code
- Z12160485 URODYNAMICS INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Urodynamic manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1620 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Urodynamic manometric catheter, non-electronic
Dual Lumen CMG/UPP Catheter 7F by Laborie Medical Technologies Canada ULC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Canada ULC
Sources (3)
- FDA UDI 93ee8953-3e67-4f11-bbb1-bd3568f1022b 32 fields · synced Sep 30, 2026
- FDA UDI 13e82112-20c0-40dd-86e9-7a2313e93f4d 32 fields · synced May 30, 2026
- EUDAMED dc0d0a11-ddb1-4cfe-bac0-6bf2e5748ef8 61 fields · synced Sep 30, 2026