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Getemed SEER 1000 Holter Recorder - HSA Registration DE0015125

Access comprehensive regulatory information for Getemed SEER 1000 Holter Recorder in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0015125 and owned by GETEMED Medizin und Informationstechnik AG. The device was registered on April 09, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0015125
Getemed SEER 1000 Holter Recorder
HSA Registration Number: DE0015125
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Product Description

The SEER 1000 digital Holter recorder is intended to continuously record ECG data. The SEER 1000 performs no cardiac analysis by itself and is intended to be used with an ECG analysis software package. The recorded data are downloaded to a PC for analysis and subsequent evaluation by a trained physician or health care professional.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0015125
Registration Date
April 09, 2014
Retention Due Date
April 08, 2026
Product Owner
Short Name
GETEMED Medizin und Informationstechnik AG
Address
Oderstrasse 77, Teltow 14513, GERMANY
Registrant
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253 1 MARITIME SQUARE, HARBOURFRONT CENTRE, #13-01, SINGAPORE 099253
Model Information
Model Name(s)
BLUESENSOR ELECTRODE 25 LR03/AAA Battery Set, alkaline (4 pcs) SEER 1000 recorder kit, 24 hour SEER 1000 recorder kit, 48 hour SEER 1000 recorder kit, 7 day Holter leadwire set, five leadwire, two channel, 61cm (24 in), IEC Holter leadwire set, seven leadwire, three channel, 61 cm (24in), IEC Holter leadwire set, five leadwire, two channel, 105 cm (41 in), IEC Holter leadwire set, seven leadwire, three channel, 105 cm (41 in), IEC Holter leadwire set, five leadwire, two channel, 61 cm (24 in), AHA Holter leadwire set, seven leadwire, three channel, 61 cm (24 in), AHA Holter leadwire set, five leadwire, two channel, 105 cm (41 in), AHA Holter leadwire set, seven leadwire, three channel, 105 cm (41 in), AHA Holter USB cable Holter leadwire set, three leadwire, three channel, 61 cm (24 in), IEC Holter leadwire set, three leadwire, three channel, 105 cm (41 in), IEC Holter leadwire set, three leadwire, three channel, 61 cm (24 in), AHA Holter leadwire set, three leadwire, three channel,105 cm (41 in), AHA Bluetooth adapter PC App (CD with App software and all user manuals) Apple App SEER 1000 battery cover (1 EA) Pouch with waist belt and shoulder belt PC App and Bluetooth kit USB Download Cable, PC App & Bluetooth Kit Pouch Belt Clip (1 EA) Pouch set w/o Belt (5 EA) Pouch Belt Clip (5 EA) SEER 1000 Waist Belt and Shoulder Strap (5 EA) SEER 1000 battery cover (5 EA)
Model Identifier(s)
2014606-093 2054933-016 2067634-001 2067634-002 2067634-003 2067634-013 2067634-014 2067634-015 2067634-016 2067634-017 2067634-018 2067634-019 2067634-020 2067634-021 2067634-050 2067634-051 2067634-052 2067634-053 2067634-054 2067634-055 2067634-056 2067634-070 2067634-073 2067634-074 2067634-165 2067634-166 2067634-167 2067634-168 2067634-169 2067634-170