gudid
Primary ID: OE-B15
PENTAX Medical (UDI OE-B15)
Manufactured by HOYA CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PENTAX Medical - Primary ID OE-B15
Device Regulatory Overview
The PENTAX Medical (Model/Catalog Number: OE-B15) is a medical device manufactured by HOYA CORPORATION. This product is indexed under FDA Product Code / Category Classification PEA within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- OE-B15
- Product Code / EMDN
- PEA
- Device Name
- PENTAX Medical Air/Water Channel Cleaning Adapter OE-B15
- Database Sync Date
- 2026-08-09 09:46:01
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of PENTAX Medical?
The registered manufacturer of record for PENTAX Medical is HOYA CORPORATION.
What is the Primary UDI-DI identifier for PENTAX Medical?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is OE-B15.
What classification code is assigned to this device?
This device is registered under product classification code PEA.
Similar Classification Devices (PEA)
Other Devices by HOYA CORPORATION
Programmatic Export
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