eudamed_udi
Primary ID: 16972857293816
Pen Needles (UDI 16972857293816)
Manufactured by Sandstone Medical(Suzhou) Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Pen Needles - Primary ID 16972857293816
Device Regulatory Overview
The Pen Needles (Model/Catalog Number: 01-3204) is a medical device manufactured by Sandstone Medical(Suzhou) Inc.. This product is indexed under FDA Product Code / Category Classification A0101010202 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 01-3204
- Product Code / EMDN
- A0101010202
- Device Name
- Pen Needles
- Database Sync Date
- 2026-08-09 16:28:48
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 Pen Needles?
The registered manufacturer of record for Pen Needles is Sandstone Medical(Suzhou) Inc..
What is the Primary UDI-DI identifier for Pen Needles?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 16972857293816.
What classification code is assigned to this device?
This device is registered under product classification code A0101010202.
Similar Classification Devices (A0101010202)
Other Devices by Sandstone Medical(Suzhou) Inc.
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