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SEER 1000 Holter leadwire set, seven lead, three channel, 75cm (29.5 in), IEC

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 2104811-001 / 85024-GModel ECG-CableRef 2067634-053 / 85031Ref 2104822-001 / 85031-GRef 2067634-050 / 85028Ref 2067634-051 / 85029Ref 2104818-001 / 85028-GRef 2104817-001 / 85027-GRef 2067634-018 / 85026Ref 2067634-020 / 85027

by GETEMED Medizin- und Informationstechnik AG

Identity

Trade Name
SEER 1000 Holter leadwire set, seven lead, three channel, 75cm (29.5 in), IEC EUDAMED
SEER 1000 Holter leadwire set, three lead, three channel,105 cm (41 in), AHA EUDAMED
SEER 1000 Holter leadwire set, three lead, three channel, 61 cm (24 in), IEC EUDAMED
SEER 1000 Holter leadwire set, three lead, three channel, 105 cm (41 in), IEC EUDAMED
SEER 1000 Holter leadwire set, three lead, three channel, 75cm (29.5 in), IEC EUDAMED
SEER 1000 Holter leadwire set, seven lead, three channel, 105 cm (41 in), AHA EUDAMED
SEER 1000 Holter leadwire set, seven lead, three channel, 61 cm (24 in), AHA EUDAMED
SEER 1000 ECG Cable FDA UDI
ECG Cable for SEER 1000 FDA UDI
Generic Name
Electrocardiographic lead set, reusable FDA UDI
Device Name
ECG-Cable EUDAMED
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
Model / Reference
ECG-Cable EUDAMED
2104811-001 / 85024-G EUDAMED
2067634-053 / 85031 EUDAMED
2104822-001 / 85031-G EUDAMED
2067634-050 / 85028 EUDAMED
2067634-051 / 85029 EUDAMED
2104818-001 / 85028-G EUDAMED
2104817-001 / 85027-G EUDAMED
2067634-018 / 85026 EUDAMED
2067634-020 / 85027 EUDAMED
3 Leads (3 Channels), 105 cm (41 in), IEC Color Code FDA UDI
7 Leads (3 Channels), 61 cm (24 in), AHA Color Code FDA UDI
3 Leads (3 Channels), 61 cm (24 in), IEC Color Code FDA UDI
7 Leads (3 Channels), 105 cm (41 in), AHA Color Code FDA UDI
7 Leads, 75 cm, IEC Color Code FDA UDI
3 Leads (3 Channels), 105 cm (41 in), AHA Color Code FDA UDI
3 Leads, 105 cm, AHA Color Code FDA UDI
3 Leads, 75 cm, IEC Color Code FDA UDI
7 Leads, 105 cm, AHA 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
2067634-051 FDA UDI
2067634-018 FDA UDI
2067634-050 FDA UDI
2067634-020 FDA UDI
2104811-001 FDA UDI
2067634-053 FDA UDI
2104822-001 FDA UDI
2104818-001 FDA UDI
2104817-001 FDA UDI
Primary DI / UDI-DI
04250903201592 EUDAMEDFDA UDI
04250903200847 EUDAMEDFDA UDI
04250903200809 EUDAMEDFDA UDI
04250903200830 EUDAMEDFDA UDI
04250903200823 EUDAMEDFDA UDI
04250903200861 EUDAMEDFDA UDI
04250903201691 EUDAMEDFDA UDI
04250903201660 EUDAMEDFDA UDI
04250903201653 EUDAMEDFDA UDI
Basic UDI-DI
0425090320234N7 EUDAMED
Direct Marketing DI
04250903201592 EUDAMED
04250903200861 EUDAMED
04250903201691 EUDAMED
04250903200830 EUDAMED
04250903200847 EUDAMED
04250903201660 EUDAMED
04250903201653 EUDAMED
04250903200809 EUDAMED
04250903200823 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 EUDAMED
Class 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

Yes

FDA UDIFDA 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

SEER 1000 Holter leadwire set, seven lead, three channel, 75cm (29.5 in), IEC by Getemed Medizin- Und Informationstechnik Ag — Class I — MDR, FDA UDI — listed…

Similar devices

Also classified as Electrocardiographic lead set, reusable.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GETEMED Medizin- und Informationstechnik AG
EUDAMED SRN
DE-MF-000012384

Sources (18)

  • EUDAMED f8eec6e2-a218-48d6-b279-0325305488e5 61 fields · synced Oct 6, 2026
  • FDA UDI d723a586-4e2a-4579-b0e5-704991ec6feb 37 fields · synced May 29, 2026
  • FDA UDI 1f3e093c-d6e2-460f-a644-145dd359bfd3 37 fields · synced May 30, 2026
  • FDA UDI 96b3869b-d056-4697-8c46-ffeabcc97f77 37 fields · synced May 30, 2026
  • FDA UDI 1f9f540c-a05b-4043-916c-0ad95175999a 37 fields · synced May 30, 2026
  • FDA UDI 5e280ff6-2ed1-4305-9e28-c76eb3c1d8c9 37 fields · synced May 30, 2026
  • FDA UDI 48602d77-44d5-476a-ac7a-c6aee6780bc0 37 fields · synced May 30, 2026
  • FDA UDI bb0134f1-c5a6-4037-b333-df311f9b6873 37 fields · synced May 30, 2026
  • FDA UDI af507b17-217b-4a45-a75e-060a6a6cdf4e 37 fields · synced May 30, 2026
  • FDA UDI 697b9495-c07f-4b44-8cad-83c307c80c37 37 fields · synced May 30, 2026
  • EUDAMED 7af82d9c-0ea9-4a08-ac19-490aff63c2d8 61 fields · synced Jul 10, 2026
  • EUDAMED f5c4d0be-915f-46f2-97b2-6270b6762b1b 61 fields · synced Jul 10, 2026
  • EUDAMED 9aadc39f-ce9e-4987-ac21-20319c344460 61 fields · synced Jul 11, 2026
  • EUDAMED 60cacc4b-1365-4ba8-a16e-8a323331ad24 61 fields · synced Jul 15, 2026
  • EUDAMED f92066f5-e6e1-494a-b881-e53778d9121a 61 fields · synced Jul 16, 2026
  • EUDAMED 7b84f701-0e9b-4359-84ff-f72447f18e5b 61 fields · synced Jul 17, 2026
  • EUDAMED 42ac7405-a062-4a8e-b7f3-d7a7765c450b 61 fields · synced Jul 20, 2026
  • EUDAMED e10eaaf5-92e5-4f85-95e1-09fcf05360d2 61 fields · synced Jul 31, 2026