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ECG Cable for SEER 1000
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 2104812-001 / 85021-GModel ECG-Cable
Identity
- Trade Name
- SEER 1000 Holter leadwire set, five lead, two channel, 105 cm (41 in), IEC EUDAMEDECG Cable for SEER 1000 FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- ECG-Cable EUDAMEDThe cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). FDA UDI
- Model / Reference
- ECG-Cable EUDAMED2104812-001 / 85021-G EUDAMED5 Leads, 105 cm, IEC Color Code FDA UDI
- Description
- The cable is intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine ( SEER 1000 recorder). FDA UDI
Identifiers
- Catalog Number
- 2104812-001 FDA UDI
- Primary DI / UDI-DI
- 04250903201608 EUDAMEDFDA UDI
- Basic UDI-DI
- 0425090320234N7 EUDAMED
- Direct Marketing DI
- 04250903201608 EUDAMED
- 510(k) Number
- K130785 FDA UDI
- FDA Product Code
- MWJ FDA UDI
- EMDN Code
- Z12050480 HOLTER SYSTEM INSTRUMENTS FOR CARDIOVASCULAR PARAMETERS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2800 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic lead set, reusable
ECG Cable for SEER 1000 by getemed Medizin- und Informationstechnik AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K130785 also covers:
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- SEER — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- ECG Cable for SEER 1000 — getemed Medizin- und Informationstechnik AG
- SEER 1000 Apple App — getemed Medizin- und Informationstechnik AG
- SEER 1000 ECG Cable — getemed Medizin- und Informationstechnik AG
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- getemed Medizin- und Informationstechnik AG
Sources (2)
- FDA UDI 5a942b56-dd9c-4e2e-83e6-2632bb264bb4 37 fields · synced Jun 19, 2026
- EUDAMED 787d783e-517b-4deb-93f3-79046a021613 61 fields · synced Jun 19, 2026