eudamed_udi
Primary ID: B108294APMEU00
FSWT applicator BTL-294-1 (UDI B108294APMEU00)
Manufactured by BTL Industries Limited
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for FSWT applicator BTL-294-1 - Primary ID B108294APMEU00
Device Regulatory Overview
The FSWT applicator BTL-294-1 (Model/Catalog Number: P094.002) is a medical device manufactured by BTL Industries Limited. This product is indexed under FDA Product Code / Category Classification Z12139001 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- P094.002
- Product Code / EMDN
- Z12139001
- Device Name
- FSWT applicator BTL-294-1
- Database Sync Date
- 2026-08-09 17:47:16
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 FSWT applicator BTL-294-1?
The registered manufacturer of record for FSWT applicator BTL-294-1 is BTL Industries Limited.
What is the Primary UDI-DI identifier for FSWT applicator BTL-294-1?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is B108294APMEU00.
What classification code is assigned to this device?
This device is registered under product classification code Z12139001.
Similar Classification Devices (Z12139001)
Other Devices by BTL Industries Limited
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