enforcement Primary ID: Z-0164-2015

Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) (UDI Z-0164-2015)

Manufactured by Siemens Healthcare Diagnostics, Inc

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

Scannable UDI-DI Representation

Device Regulatory Overview

The Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) (Model/Catalog Number: Unspecified) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc. This product is indexed under FDA Product Code / Category Classification 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-2753-2026 View Full Alert →

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ID: Z-2755-2026 View Full Alert →

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Technical Specifications

Model Number: N/A
Product Code / EMDN: 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39
Device Name: Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Database Sync Date: 2026-08-09 10:06:44

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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Frequently Asked Questions

Who is the primary manufacturer of Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)?

The registered manufacturer of record for Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref) is Siemens Healthcare Diagnostics, Inc.

What is the Primary UDI-DI identifier for Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0164-2015.

What classification code is assigned to this device?

This device is registered under product classification code 26284A38, 26900A38, 27991A38, 28192A38, 29571A38, 31162A38, 32488A38, 35243AB39, 35295AB39, 36091AB39, 39464AB39, 40245AB39, 41317AB39, 26285A38, 27348A38, 29169A38, 30710A38, 31261A38, 32687A38, 35259AB39, 35359AB39, 36289AB39, 39031AB39, 41124AB39, 27236A38, 35051A38, 35839AB39, 40141AB39, 41702AB39.

Other Devices by Siemens Healthcare Diagnostics, Inc

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