gudid
Primary ID: 20ml
Wealy (UDI 20ml)
Manufactured by Shantou Wealy Medical Instrument Co., Ltd.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Wealy - Primary ID 20ml
Device Regulatory Overview
The Wealy (Model/Catalog Number: 20ml) is a medical device manufactured by Shantou Wealy Medical Instrument Co., Ltd.. This product is indexed under FDA Product Code / Category Classification PNR within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 20ml
- Product Code / EMDN
- PNR
- Device Name
- The ENFit Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
- Database Sync Date
- 2026-08-09 09:06:43
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 Wealy?
The registered manufacturer of record for Wealy is Shantou Wealy Medical Instrument Co., Ltd..
What is the Primary UDI-DI identifier for Wealy?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 20ml.
What classification code is assigned to this device?
This device is registered under product classification code PNR.
Similar Classification Devices (PNR)
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