TECAN CDMO SOLUTIONS PN SDN. BHD.

FDA Device Registration & Listing · Penang Pulau Pinang, MY · Registration 3015134086

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015134086
FEI Number
3015134086
Entity Name
TECAN CDMO SOLUTIONS PN SDN. BHD.
City/State/Country
Penang Pulau Pinang, MY
Establishment Address
PMT1199 (Plot 372), Penang Science Park, Lorong Perindustrian Bukit Minyak 21, Taman Perindustrian, Bukit Minyak, 14100 Simpang Ampat, Seberang Perai Tengah,, Penang Pulau Pinang 14100, MY
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CORE DIGITAL ATTACHMENT PRIMARY BOX FG SKU KARDIAMOBILE 6L_AliveCor, Inc. KardiaMobile System KardiaMobile System Kardia 12L Medical Device Data System_Avail Medsystem Inc. Avive Connect

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DQD Stethoscope, Electronic Cardiovascular Class 2 870.1875 2024-06-01
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2021-10-14
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2021-10-14
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2021-10-14
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-06-08
QDA Electrocardiograph Software For Over-The-Counter Use Cardiovascular Class 2 870.2345 2024-12-24
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2024-12-24
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-12-24
DXH Transmitters And Receivers, Electrocardiograph, Telephone Cardiovascular Class 2 870.2920 2025-01-16
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2024-06-10
OUG Medical Device Data System General Hospital Class 1 880.6310 2021-10-08

Official Correspondent

No official correspondent registered.

US Agent Details

Angela Curtis Email: angela.curtis@tecan.com Phone: (707) 9801918

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
K771506 Swartz Medical Equipment STETHOSCOPE 1977-08-26
K082528 Noble Anesthesia-Air, Inc. SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM 2009-03-06
K862544 Suzuken Co., Ltd. KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH 1986-08-06
K802368 Marquette Electronics, Inc. OPTION 301 PACEMAKER EVAL. MODULE MAC-1 1981-03-04
K131503 Edan Instruments, Inc. SE-601 SERIES ELECTROCARDIOGRAPH 2014-02-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2022 Welch Allyn Inc Mortara 2
ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX, ELI280-BDB-ACAAX, ELI280-CAA-AAFAD, ELI280-BDB-BDFAX, ELI280-BCB-AAAAX, ELI280-DDB-ACAAX, ELI280-DBA-BAFAX, ELI280-DCB-AAAAX, ELI280-DBA-AAFBD, ELI280-AAA-AAEBX, ELI280-BBA-ADFBD, ELI280-DDB-ACFAX, MLBUR280-81X, ELI280-CAA-ACEBX, ELI280-AAA-AAHBX, ELI280-DDB-BDFAX, ELI280-CAA-AAFBT, ELI280-DCD-ADFAD, ELI280-DDB-AACBX, ELI280-JXX-BDFAX, ELI280-CAA-ADCBX, ELI280-BCB-AACBD, ELI280-LDX-ADFBX, ELI280-LDX-ADCBX, ELI280-BDD-ADFAD, ELI280-BDB-AAFBD, ELI280-BDB-ACCAD, ELI280-BDB-ADFAD, ELI280-LDX-ADFBD, ELI280-DDB-AAFBD, ELI280-DCB-ACFAD, ELI280-AAA-BAFAF, MLBUR280-W1X, ELI280-DCB-AAABX, ELI280-AAA-ACAAX, ELI280-ADA-ABFBX, ELI280-BCB-AAFBD, ELI280-BCB-AAFBX, ELI280-CEA-ADFBX, ELI280-CDA-ADABX, ELI280-BDB-AAABX, ELI280-DDB-ACFBD, ELI280-DDB-BCFAX, ELI280-ADA-ADCAX, ELI280-BDB-AACBX, ELI280-BCB-ACAAX, BUR280-81X, ELI280-DCB-AAFBG, ELI280-BDB-AAFBT, ELI280-DCB-AAFAD, ELI280-CAA-ADFBX, ELI280-BDB-AAFBG, ELI280-BDB-AAFBX, ELI280-DCA-ACAAX, ELI280-CAB-ACFBX, ELI280-ADA-ACFAX, ELI280-CAA-AAFAT, ELI280-CAA-ACFBD, ELI280-CDA-ADCBX, ELI280-AAA-ADCBX, ELI280-CAA-AAFBD, ELI280-DCB-BAFBT, ELI280-BBA-AAAAX, ELI280-BBA-AAFAD, ELI280-DBA-AAFAD, ELI280-DCB-AAFBT, ELI280-DBA-ADFAX, ELI280-BBA-AAFBD, MLBUR280-C1X, ELI280-BBA-ADFAX, ELI280-DDD-ADFAD, ELI280-DBA-AAFAX, MLBUR280-W1D, ELI280-BCB-AACBX, ELI280-DCB-AACBD, ELI280-LDX-ADFBG, ELI280-DCB-AACBX, ELI280-DBA-ADFBD, ELI280-DDB-AAFBG, ELI280-DBA-AAABD, ELI280-DCB-AAFBX, ELI280-AAA-AAFBT, MLBUR280-C1D, ELI280-AAB-ADAAX, ELI280-DDB-AAFBT, ELI280-CAA-AACBX, ELI280-CEB-ACFBX, ELI280-CAA-ABFAX, ELI280-DDB-AAFBX, ELI280-DBA-AAAAX, ELI280-BCB-AAFBG, ELI280-BFA-ADCBX, ELI280-LDX-ADABX, MLBUR280-81D, ELI280-BBA-ADFAD, ELI280-CAA-ADHAX, ELI280-CEB-ACFBD, ELI280-AAB-ADCAD, ELI280-BDB-AACBD, ELI280-LDX-ADCBD, ELI280-AAB-ACCBX, ELI280-AAA-ABFBX, ELI280-DAB-ADCAD, ELI280-AFB-ABCBX, ELI280-DCB-AACAX, ELI280-DEB-ACFBD, ELI280-ADA-ACAAX, ELI280-AAB-ADFAD, ELI280-DCB-AAFBD, ELI280-CAA-AAAAX, ELI280-BDB-ACCAX, ELI280-CAA-AAFBX, ELI280-DDB-AAABX, ELI280-DCB-ACAAX, ELI280-CAA-ADFBD, ELI280-CBB-ACCBX, ELI280-DDB-AACBD, ELI280-DDB-ACCAX, ELI280-A, ELI280-DFA-ADCBX, ELI280-BCA-AAAAX, ELI280-DDB-AAAAX, ELI280-E, ELI280-C, ELI280-AAA-AAFBD, ELI280-DFC-ADFAD, BUR280-C1X, ELI280-D, ELI280-BAA-ACCBD, ELI280-AAA-AAAAX, BUR280-W1X, ELI280-B, ELI280-BCB-AAABX, ELI280-BCB-AACAX, BUR280-W1D, ELI280-F, ELI280-BCB-AAFAD, ELI280-BCB-BAFAX, BUR280-81D
Z-0041-2012 Edan Instruments, Inc. 7/F, Yuehai Office Bldg. 1128 Nanyou Road Nanshan, Shenzhen Guangdong China 2
ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015134086. Last updated year: 2026. Please use registration number 3015134086 when referencing this establishment in official correspondence.
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