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Sign in to claim this brandLaborie Medical Technologies Corp.
United States·US-MF-000022925
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 180 International Drive , Portsmouth, United States
- Website
- laborie.com
- —
- —
- [email protected]
- Phone
- 18012606086
- PRRC Contact
- Thomas Hirte
- EUDAMED SRN
- US-MF-000022925
- FDA FEI Number
- 3017448360
- DUNS Number
- —
Catalogue (88)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| e•Sense 7Fr Single Sensor Coudé Bladder Catheter | CATEB27C | FDA UDI | Class II | Active |
| SOLAR Anorectal Manometry Catheter | K1210AC-L-2212 | FDA UDI | Class II | Active |
| e•Sense 7Fr Dual Sensor Urethral Catheter | CATEB37 | FDA UDI | Class II | Active |
| Nxt | NXT2300 | FDA UDI | Class II | Active |
| Nxt | TRA7002 | FDA UDI | Class II | Active |
| PIM NXT for eSense | PIX7000 | FDA UDI | Class II | Active |
| T-DOC 5Fr Air-Charged Single Sensor Catheter | CAT595P | FDA UDI | Class II | Active |
| SOLAR Anorectal Manometry Charger | ZM12-AC59-2213 | FDA UDI | Class II | Active |
| T-DOC 5Fr Air-Charged Single Sensor Catheter | CAT595S | FDA UDI | Class II | Active |
| NXT EMG cable, Long, 1-channel | CAB1092 | FDA UDI | Class II | Active |
| T-DOC 5Fr Air-Charged Abdominal Sensor Catheter | CAT575 | FDA UDI | Class II | Active |
| SOLAR Compact | G4-1 | FDA UDI | Class II | Active |
| Nxt | TRA7001 | FDA UDI | Class II | Active |
| Nxt | NXT2400 | FDA UDI | Class II | Active |
| Nxt | TRA7000 | FDA UDI | Class II | Active |
| e•Sense 7Fr Abdominal Catheter | CATEA17 | FDA UDI | Class II | Active |
| e•Sense 7Fr Single Sensor Bladder Catheter | CATEB27 | FDA UDI | Class II | Active |
| e•Sense 7Fr Dual Sensor Coudé Uretheral Catheter | CATEB37C | FDA UDI | Class II | Active |
| NXT EMG cable, Short, 1-channel | CAB1091 | FDA UDI | Class II | Active |
| Nxt | TRA7003 | FDA UDI | Class II | Active |
| Air-Charged Reusable Cable | TRA622 | EUDAMEDFDA UDI | Class I | Active |
| Cbl, Sedia, P4 | CAB4520P4 | EUDAMEDFDA UDI | Class I | Active |
| T-DOC Air-Charged Single Sensor Catheter | CAT895 | EUDAMEDFDA UDI | Class IIa | Active |
| Transducer TDOC cable, Vesical, 25cm | CAB4065V-25cm | EUDAMEDFDA UDI | Class I | Active |
| Air-Charged Reusable Cable | TRA616 | EUDAMEDFDA UDI | Class I | Active |
| T-DOC Air-Charged Single Sensor Catheter, Radiopaque | CAT905 | EUDAMEDFDA UDI | Class IIa | Active |
| Air-Charged Reusable Cable | CAB734 | EUDAMEDFDA UDI | Class I | Active |
| Medex Pressure Cable, P2 | CAB1038 | EUDAMEDFDA UDI | Class I | Active |
| Urodynamics Measurement Tubing | TUB101 | EUDAMEDFDA UDI | Class IIa | Active |
| Air-Charged Reusable Cable | CAB4060VS | EUDAMEDFDA UDI | Class I | Active |
| Air-Charged Reusable Cable | TRA618 | EUDAMEDFDA UDI | Class I | Active |
| Solar Compact (G4-1) | K240007 | FDA 510(k) | Class II | Active |
| Dri Sleeper | K934369 | FDA 510(k) | Class II | Active |
| Laborie Urodynamic System With Tetra Accessory | K073552 | FDA 510(k) | Class II | Active |
| Advance Model Uds-Adv | K931574 | FDA 510(k) | Class II | Active |
| Dritrainer | K930005 | FDA 510(k) | Class II | Active |
| Nuwav | K081781 | FDA 510(k) | Class II | Active |
| Infusion Pump, Model No. Udp-5 | K942023 | FDA 510(k) | Class II | Active |
| Laborie Injetak Adjustable Tip Needle, Flexible Tip And Ridgid Tip | K090830 | FDA 510(k) | Class II | Active |
| Nicki, Model Number Usd-Nk-Up1 | K924086 | FDA 510(k) | Class II | Active |
| Evox Electro Diagnostic Device | K082614 | FDA 510(k) | Class II | Active |
| Tex-Aid Blue | K955856 | FDA 510(k) | Class II | Active |
| Urostym Biofeedback And Stimulation Device And Accessories | K070331 | FDA 510(k) | Class II | Active |
| Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | K234107 | FDA 510(k) | Class II | Active |
| U-Tex | K955810 | FDA 510(k) | Class I | Active |
| Piper, Model Number Uds-Piperb | K951805 | FDA 510(k) | Class II | Active |
| Elite Biofeedback | K942563 | FDA 510(k) | Class II | Active |
| T-DOC Air-Charged Catheters | CAT875 | EUDAMEDFDA UDI | Class IIa | Active |
| EMG Cable Extension, Non-shielded | CAB143 | EUDAMEDFDA UDI | Class I | Active |
| Air-Charged Reusable Cable | TRA619 | EUDAMEDFDA UDI | Class I | Active |
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 17, 2019 | Z-2076-2019 | — | terminated | Power supply unit (PS-SBL) not correctly labeled, and insulation material used at the low voltage DC end does not meet all applicable flammability rating requirements. may lead to a potential fire hazard |
| Oct 4, 2006 | Z-0229-2007 | — | terminated | Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041 |