Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

15-30-100 — Class I MDR by Ganshorn Medizin…

MD Atlas
Ganshorn Medizin Electronic GmbH

EUDAMED last updated this device on Nov 4, 2025

15-30-100

7613365SANASED2B

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ganshorn Medizin Electronic GmbH
UDI-DI code: 07613365500813
Reference / catalog number: 15-30-100

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Ganshorn Medizin Electronic GmbH
SRN: DE-MF-000006566
Manufacturer status: Active

Related devices

0194109087613365NOSCL3MOn the market 0500000007613365PWCBD2YOn the market 0500000007613365PWCBD2YOn the market 0500000007613365PWCBD2YOn the market 0500000007613365PWCBD2YOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW273
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 07613365500813
Basic UDI-DI: 7613365SANASED2B
Reference / catalog number: 15-30-100
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using either their legs or arms and is intended for use during assessment, treatment, and training to measure muscle performance and activity at adjustable, defined workloads. The device can be integrated with diagnostic tools such as stress electrocardiography (ECG) and/or stress echocardiography. The ergometers are intended for use in hospital and clinic settings.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification