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

LM000094 — Class IIb MDR by LAUDA Medical GmbH &…

MD Atlas
LAUDA Medical GmbH & Co. KG

EUDAMED last updated this device on May 22, 2026

LM000094

426248181HYPODY

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: LAUDA Medical GmbH & Co. KG
UDI-DI code: 04262481810196
Reference / catalog number: LM000094

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: LAUDA Medical GmbH & Co. KG
SRN: DE-MF-000027737
Manufacturer status: Active

Critical warnings

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

CW999
Waste Electrical and Electronic Equipment Directive (WEEE Directive 2012/19/EU) Electronic Equipment - DO NOT THROW IT IN TRASH

Market distribution

Primary placement in Poland; available across 3 countries total.

Country	On market since	Until
PolandPrimary placement		Still on market
Czechia		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262481810196
Basic UDI-DI: 426248181HYPODY
Reference / catalog number: LM000094
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The device HYPO is used to cool/heat and maintain the required temperature of a patient connected to the extracorporeal perfusion circuit (e.g. a heart-lung machine). The temperature is transferred via a heat exchanger (part of the oxygenator) in the patient's perfusion circuit (hypothermia treatment). In addition to hypothermia treatment, the device HYPO can also be used to cool a cardioplegia solution via an additional heat exchanger. The device HYPO is designed for a treatment duration of 6 hours per use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12040208BODY THERMOREGULATION EQUIPMENT

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

Related devices

LM000097426248181HYPODYOn the market LM000091426248181HYPODYOn the market LM000090426248181HYPODYOn the market LM000092426248181HYPODYOn the market LM000096426248181HYPODYOn 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.