eudamed_udi
Primary ID: 04028698132557
Ocean Ergo XL (UDI 04028698132557)
Manufactured by Invacare GmbH
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ocean Ergo XL - Primary ID 04028698132557
Device Regulatory Overview
The Ocean Ergo XL (Model/Catalog Number: 1604210) is a medical device manufactured by Invacare GmbH. This product is indexed under FDA Product Code / Category Classification Y091203 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 1604210
- Product Code / EMDN
- Y091203
- Device Name
- Ocean Ergo
- Database Sync Date
- 2026-08-09 16:29:41
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 Ocean Ergo XL?
The registered manufacturer of record for Ocean Ergo XL is Invacare GmbH.
What is the Primary UDI-DI identifier for Ocean Ergo XL?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04028698132557.
What classification code is assigned to this device?
This device is registered under product classification code Y091203.
Similar Classification Devices (Y091203)
Other Devices by Invacare GmbH
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