ECG Cable for CM 3000-12 BT / SEER 12

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2104808-001 / 90207-REL-GModel ECG-Cable

by getemed Medizin- und Informationstechnik AG

Identity

Trade Name: SEER 12 12-CHANNEL HOLTER ECG CABLE, ROUND, IEC, 130 CM EUDAMED
ECG Cable for CM 3000-12 BT / SEER 12 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 (CM 3000-12 BT, SEER 12 recorder). FDA UDI
Model / Reference: ECG-Cable EUDAMED
2104808-001 / 90207-REL-G EUDAMED
10 Leads, 130 cm, IEC Color Code, Round 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 (CM 3000-12 BT, SEER 12 recorder). FDA UDI

Identifiers

Catalog Number: 2104808-001 FDA UDI
Primary DI / UDI-DI: 04250903201707 EUDAMEDFDA UDI
Basic UDI-DI: 0425090320234N7 EUDAMED
Direct Marketing DI: 04250903201707 EUDAMED
510(k) Number: K063042 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

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electrocardiographic lead set, reusable

ECG Cable for CM 3000-12 BT / SEER 12 by getemed Medizin- und Informationstechnik AG — Class II — MDR, MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as Electrocardiographic lead set, reusable.

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Unimed — Unimed Medical Supplies, Inc. · Class II
Reusable EKG / ECG Leadwire — METKO MEDİKAL VE TIBBİ CİHAZLAR DIŞ TİCARET SANAYİ ANONİM ŞİRKETİ · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
ECG D-SUB2 C 3.5/3.1 x14 AHA — Schiller AG · Class I
Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II

Cleared under the same submission

K063042 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
EUDAMED	European Union	MDD	—	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 577ed1e0-fe1d-4c16-9c78-400673128896 37 fields · synced Aug 4, 2026
EUDAMED e8756a0f-c92d-4531-97c2-a10874783553 61 fields · synced Aug 4, 2026