Identity
- Trade Name
- 3950c Visi-Pitch EUDAMEDVISI-PITCH FDA UDI
- Generic Name
- Speech assistive training device FDA UDI
- Device Name
- 3950c Visi-Pitch EUDAMEDVISI-PITCH FDA UDI
- Model / Reference
- 3950c EUDAMEDFDA UDI
- Description
- VISI-PITCH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333235438 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333033950cTU EUDAMED
- FDA Product Code
- KLX FDA UDI
- EMDN Code
- V030208 ENT MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Speech assistive training device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1325 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
3950c Visi-Pitch by PENTAX of America, Inc. — 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 | 4961333033950cTU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America Inc.
- EUDAMED SRN
- US-MF-000008135
- Authorised Representative
- PENTAX Europe GmbH DE-AR-000000006
Sources (2)
- EUDAMED 81224acd-1345-4bc6-b787-86911c055c2c 61 fields · synced Jul 17, 2026
- FDA UDI ad574508-105b-426a-8b1b-70e2f2410f03 33 fields · synced May 30, 2026