Identity
- Trade Name
- Phonatory Aerodynamic System (PAS) EUDAMEDPHONATORY AERODYNAMIC SYSTEM FDA UDI
- Generic Name
- Speech assistive training device FDA UDI
- Device Name
- Phonatory Aerodynamic System (PAS) EUDAMEDPHONATORY AERODYNAMIC SYSTEM FDA UDI
- Model / Reference
- 6600 EUDAMEDFDA UDI
- Description
- PHONATORY AERODYNAMIC SYSTEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333247424 EUDAMEDFDA UDI
- Basic UDI-DI
- 496133303660026 EUDAMED
- Direct Marketing DI
- 04961333247424 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
Category: Speech assistive training device
Phonatory Aerodynamic System by PENTAX of America, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (2)
- FDA UDI 788c82a1-1cbd-44cc-9454-46d4e508ce30 33 fields · synced Jul 10, 2026
- EUDAMED 7d23fd08-c609-417b-add3-9f3edc7cd3d1 61 fields · synced Jul 10, 2026