Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614485

FEI Number

3002673652

Entity Name

NDD MEDIZINTECHNIK AG

City/State/Country

ZURICH, CH

Establishment Address

TECHNOPARKSTRASSE 1, ZURICH CH-8005, CH

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

ndd Medizintechnik AG (Owner Number: 9040235)

Owner / Operator Contact Address

Technoparkstrasse 1, Zurich, CH-ZH CH-8005, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091428

PMA Number

N/A

All Registered Proprietary Names

Spiro-SP TrueFlow Sensor EasyOne Sky Spirometer EasyOne Pro LAB Respiratory Analysis System EasyOne Pro/Pro LAB EasyOne Spirometer Easy on-PC Spirometer EasyOne Air Spirometer EasyOne Filter SP EasyOne Filter FT EasyOne Pro Respiratory Analysis System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2021-02-15
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2024-09-25
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2012-11-01
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2017-04-04
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2007-11-20
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2009-12-11
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2017-01-10
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2022-12-02
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2010-12-11

Official Correspondent

Roman Eicher

US Agent Details

Joy Tobin Business: ndd Medical Technologies Email: jtobin@nddmed.com Phone: (978) 4700923

Related Public Records

Same Entity

ndd Medizintechnik AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Similar Registrations

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9710567	Besmed Health Business Corporation	New Taipei City, TW
3012309966	ENGLERT GMBH & CO. KG	Wertheim Baden-Wurttemberg, DE
3010370454	SENSATRONIC GMBH	Wismar Mecklenburg-Western Pomerania, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614485. Last updated year: 2026. Please use registration number 9614485 when referencing this establishment in official correspondence.