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No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

PENTAX of America Inc.

SRN US-MF-000008135

manufacturer · Montvale, US · 24 devices

3 Paragon Drive, 07645

Devices

NameUDI-DIClassBadge
3950c Visi-Pitch04961333235438Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Adult Face Mask, Extra04961333230082Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Adult Large Disposable Masks04961333231065Class I
No Certificate Found

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Adult Small Disposable Masks04961333231041Class I
No Certificate Found

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Adult Small Disposable Masks04961333231058Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Airflow Head‑Mask Couplers04961333230129Class I
No Certificate Found

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Cardboard Tubes (Disposable)04961333230105Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Computerized Speech Lab (CSL) 4500b04961333235445Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Digital Capture04961333248117Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Flowhead, Extra04961333230075Class I
No Certificate Found

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Flowhead Tubes04961333230501Class I
No Certificate Found

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Intra‑Oral Tubes04961333229918Class I
No Certificate Found

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LARYNGEAL STROBE 940004961333240685Class I
No Certificate Found

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LARYNGEAL STROBE 950004961333255016Class I
No Certificate Found

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Microphone Assembly Kit04961333255979Class I
No Certificate Found

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Nasometer04961333247318Class Im
No Certificate Found

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PAS Tubing Kit04961333255986Class I
No Certificate Found

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Pediatric Disposable Masks04961333231034Class I
No Certificate Found

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Pediatric Mask with Adaptor04961333230099Class I
No Certificate Found

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Phonatory Aerodynamic System (PAS)04961333247424Class I
No Certificate Found

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Phonatory Aerodynamic System (SOFTWARE)04961333236565Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Pressure Port Tubes04961333230136Class I
No Certificate Found

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Screening Tubes04961333230112Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

Switch Box Assembly A‑B04961333231553Class I
No Certificate Found

Snapshot 2026-10-25 · Link to EUDAMED

PENTAX of America Inc. (SRN US-MF-000008135) — registered devices | UDI Compass