eudamed_udi Primary ID: 06976485025750

Pylon Procalcitonin (UDI 06976485025750)

Manufactured by ET Healthcare (Suzhou) Co., Ltd.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The Pylon Procalcitonin (Model/Catalog Number: 10-2257 40 tests/kit) is a medical device manufactured by ET Healthcare (Suzhou) Co., Ltd.. This product is indexed under FDA Product Code / Category Classification W0102069013 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: 10-2257 40 tests/kit
Product Code / EMDN: W0102069013
Device Name: Pylon Procalcitonin
Database Sync Date: 2026-08-09 16:51:54

Full Regulatory Attributes

🔒 Token Gated

{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of Pylon Procalcitonin?

The registered manufacturer of record for Pylon Procalcitonin is ET Healthcare (Suzhou) Co., Ltd..

What is the Primary UDI-DI identifier for Pylon Procalcitonin?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 06976485025750.

What classification code is assigned to this device?

This device is registered under product classification code W0102069013.

Similar Classification Devices (W0102069013)

Other Devices by ET Healthcare (Suzhou) Co., Ltd.

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint