ROM Hinge Knee Support (UDI 04712302980565)
Manufactured by e-life International Co., Ltd.
Device Regulatory Overview
The ROM Hinge Knee Support (Model/Catalog Number: MKNNP92 (L/UNI/BG)) is a medical device manufactured by e-life International Co., Ltd.. This product is indexed under FDA Product Code / Category Classification Y061209 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MKNNP92 (L/UNI/BG)
- Product Code / EMDN
- Y061209
- Device Name
- Knee orthosis and tubular support bandage
- Database Sync Date
- 2026-08-09 16:28:51
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 ROM Hinge Knee Support?
The registered manufacturer of record for ROM Hinge Knee Support is e-life International Co., Ltd..
What is the Primary UDI-DI identifier for ROM Hinge Knee Support?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04712302980565.
What classification code is assigned to this device?
This device is registered under product classification code Y061209.
Similar Classification Devices (Y061209)
Other Devices by e-life International Co., Ltd.
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