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Cable, Urostym, Channel 1
EUDAMEDFDA UDIClass I (EU MDR)
Ref CAB896Model CAB1036
Identity
- Trade Name
- Cable, Urostym, Channel 1 EUDAMEDUrostym EMG Stimulation Cable, Ch 1 FDA UDI
- Generic Name
- Analytical non-scalp cutaneous lead FDA UDI
- Device Name
- Medex Pressure Cable, P1 EUDAMEDUrostym EMG Stimulation Cable, Ch 1 FDA UDI
- Model / Reference
- CAB1036 EUDAMEDCAB896 EUDAMEDFDA UDI
- Description
- Urostym EMG Stimulation Cable, Ch 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00627825014540 EUDAMEDFDA UDI
- Basic UDI-DI
- 0627825CABA9 EUDAMED
- 510(k) Number
- K070331 FDA UDI
- FDA Product Code
- KPI FDA UDI
- EMDN Code
- U0580 URODYNAMICS DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Analytical non-scalp cutaneous lead FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5320 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cable, Urostym, Channel 1 by Laborie Medical Technologies Corp. — 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 | 0627825CABA9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Laborie Medical Technologies Corp.
- EUDAMED SRN
- US-MF-000022925
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED bd507253-0c9f-412a-88d2-657c1f119be0 61 fields · synced Jul 25, 2026
- FDA UDI 451e1d1f-bf9a-4560-a370-04f467b4b8a9 35 fields · synced May 30, 2026