eudamed_udi
Primary ID: 00661613003712
UltraMax (UDI 00661613003712)
Manufactured by Marlen Mfg. & Development Co.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for UltraMax - Primary ID 00661613003712
Device Regulatory Overview
The UltraMax (Model/Catalog Number: 115212) is a medical device manufactured by Marlen Mfg. & Development Co.. This product is indexed under FDA Product Code / Category Classification A1001020102 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 115212
- Product Code / EMDN
- A1001020102
- Device Name
- Ileostomy Pouch
- Database Sync Date
- 2026-08-09 16:47:08
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 UltraMax?
The registered manufacturer of record for UltraMax is Marlen Mfg. & Development Co..
What is the Primary UDI-DI identifier for UltraMax?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00661613003712.
What classification code is assigned to this device?
This device is registered under product classification code A1001020102.
Similar Classification Devices (A1001020102)
Other Devices by Marlen Mfg. & Development Co.
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