Identity
- Trade Name
- IOPI® EUDAMEDFDA UDI
- Generic Name
- Dynamometer force gauge FDA UDI
- Device Name
- IOPI Report Generator EUDAMEDIOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only. FDA UDI
- Model / Reference
- v 1.0 EUDAMED5-8101 EUDAMEDReport Generator v 1.0 FDA UDI
- Description
- IOPI® Report Generator software is an accessory approved for use with the IOPI® Model 3.1 (Pro) and/or the Model 3.2 (Trainer), which are medical devices that measure, evaluate, and increase the strength and endurance of the tongue and lip in patients with oral motor disorders, including dysphagia, dysarthria, and obstructive sleep apnea. This software provides healthcare professionals with a report of device usage to allow them to document and analyze patient progress and usage. This software is intended for clinical use only. FDA UDI
Identifiers
- Catalog Number
- 5-8101 FDA UDI
- Primary DI / UDI-DI
- 10810091040284 EUDAMEDFDA UDI
- Basic UDI-DI
- 081009104ReportGenV1S9 EUDAMED
- FDA Product Code
- IKE FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Dynamometer force gauge FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1615 FDA UDI
- Market of Registration
- Ireland 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Iopi® by IOPI Medical LLC — 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 | 081009104ReportGenV1S9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IOPI Medical LLC
- EUDAMED SRN
- US-MF-000035535
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b57499bb-296e-4ae4-bb3c-b02528cd0ecb 61 fields · synced Jun 1, 2026
- FDA UDI eb6f1464-b736-4e24-bca5-e79f60b30e56 35 fields · synced May 30, 2026