Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003537036

FEI Number

3003537036

Entity Name

TECAN CDMO SOLUTIONS MH, CORP.

City/State/Country

MORGAN HILL, CA, US

Establishment Address

18735 MADRONE PKWY., MORGAN HILL, CA 95037, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tecan Group AG (Owner Number: 9050992)

Owner / Operator Contact Address

103 Seestrasse, --, Maennedorf, CH-ZH 8708, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accuryn Monitoring System; Accuryn SmartFoley IAP UO Temp Tray System; Accuryn SmartFoley UO Temp Tray System Medical Device Data System_Avail Medsystem Inc. Avive Connect CATALYS Precision Laser System (Mobile Patient Bed)- JNJ E-100 Electrosurgical Generator, SynchroSeal

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHU	Intra-Abdominal Pressure Monitoring Device	Unknown	Class U	N/A	2021-11-04
EXY	Uroflowmeter	Gastroenterology, Urology	Class 2	876.1800	2021-11-04
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2026-02-05
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2023-06-08
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2021-10-08
OOE	Ophthalmic Femtosecond Laser	Ophthalmic	Class 2	886.4390	2021-11-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-10-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tecan Group AG

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010160459	Tecan Software Competence Center GmbH	Mainz-Kastel Rhineland-Palatinate, DE
3003559191	Tecan Trading AG	Maennedorf Zurich, CH
3003402518	TECAN SCHWEIZ AG	MAENNEDORF ZUERICH Zurich, CH
9710337	IBL INTERNATIONAL GMBH	HAMBURG, DE
3002710220	TECAN AUSTRIA GMBH	GROEDIG Salzburg, AT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170322	Abbott Medical Optics, Inc.	Catalys Precision Laser System	2017-05-19
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2010	Philips Healthcare Inc.	3	HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician.
Z-0004-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK 500 AED.
Z-0004-2017	Leonhard Lang Medizintechnik GmbH Archenweg 56 Innsbruck Austria	3	Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Z-0005-06	Medtronic Emergency Response Systems, Inc.	3	Hard shell carry case for the LIFEPAK CR Plus.
Z-0011-2013	Philips Healthcare Inc.	3	Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation of the device, in a hospital environment.

Similar Registrations

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3011383638	POTRERO MEDICAL, INC.	Hayward, CA, US
9611590	PRODUCTOS PARA EL CUIDADO DE LA SALUD	NOGALES Sonora, MX
3021468326	SENTINEL MEDICAL TECHNOLOGIES, LLC	Jacksonville, FL, US
3006082230	C.R. BARD, INC.	MADISON, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003537036. Last updated year: 2026. Please use registration number 3003537036 when referencing this establishment in official correspondence.