Who else makes this device?

Name: Ambu Concentric ProbeSingle Patient Probes
Brand: Ambu Concentric ProbeSingle Patient Probes

Ambu Concentric ProbeSingle Patient Probes

Ambu Disposable IOM Stimulation Probes 100 mm long Concentric with 1,5 mm connector and 1,9 m. attached cable 10 probes per box = min. sale

Registry build 21.09.26

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (2), Shandong (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GXZ
Manufacturer	City	Province	Registered as	Device types
Xian Friendship Medical Electronics Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	10
Shenzhen Launch Electrical Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Pine Moon Electronics Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
BIO Protech Yantai Inc	Yantai	Shandong	Manufacturer	12

Record

Regulatory record for Ambu Concentric ProbeSingle Patient Probes
Listed by	Ambu A/S, Denmark
FDA product code	GXZ
Device type	Electrode, Needle
Device class	Class 2
Regulation	21 CFR 882.1350
Establishment	Specification developer, Private-label distributor, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2026-01-30 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Storage environment temperature 10 to 40 °C
Packaging	Pack of 10, pack of 34
Sizes	Length 100 mm; length 190 cm

Catalogue Numbers

Catalogue numbers for Ambu Concentric ProbeSingle Patient Probes
Catalogue number	Size	Status
73603-190/10	Length 100 mm	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Rhythmlink®	Rhythmlink International, LLC	204
Technomed Europe	Technomed Engineering B.V.	114
Electrode, Needle	Medtronic Xomed, Inc.	82
Horizon™	Rochester Electro Medical, Inc.	68
Spes Medica Subdermal Needle Electrodes	Spes Medica Srl	66
Friendship Medical	Xi’an Friendship Medical Electronics Co., Ltd.	66
Cadwell	Technomed Engineering B.V.	61
The Electrode Store	Impulse Technology LLC	56
Horizon™	LifeSync Corporation	55
Rochester	Rochester Electro Medical, Inc.	41
Temena	Temena GmbH	34
Cadwell	Xi’an Friendship Medical Electronics Co., Ltd.	33

Showing 12 of 106. All products under Electrode, Needle

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K071185	2007-05-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.