Identity
- Trade Name
- Computerized Speech Lab (CSL) 4500b EUDAMEDN/A FDA UDI
- Generic Name
- Speech assistive training device FDA UDI
- Device Name
- Computerized Speech Lab (CSL) 4500b EUDAMEDCOMPUTERIZED SPEECH LAB FDA UDI
- Model / Reference
- 4500b EUDAMEDFDA UDI
- Description
- COMPUTERIZED SPEECH LAB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333235445 EUDAMEDFDA UDI
- Basic UDI-DI
- 4961333034500bSG 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
Computerized Speech Lab (CSL) 4500b 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 | 4961333034500bSG | 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 1b70332b-27cc-467e-bb91-7b8a04a90222 61 fields · synced Jun 18, 2026
- FDA UDI 4c3964b3-ab06-4687-b684-77587ca2e3e5 33 fields · synced May 25, 2026