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Organization name
UDI-DI code
Reference / catalog number

Nasenmanschette T-Gips -… — Class I MDR by HILOTHERM GmbH

MD Atlas
HILOTHERM GmbH

EUDAMED last updated this device on Mar 24, 2026

Nasenmanschette T-Gips - Marienhospital EM

42503871MANEMFP

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HILOTHERM GmbH
UDI-DI code: 04250387102088
Reference / catalog number: 15000021

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Manufacturer information

Organization name: HILOTHERM GmbH
SRN: DE-MF-000006176
Manufacturer status: Active

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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

4 warnings recorded — scroll inside the panel to see all entries.

CW262
Each cuff may only be used on one patient
CW010
Die Gebrauchsanweisung der Hilotherm Geräte muss beachtet werden.
CW999
Apply only to intact skin
CW999
Check for leaks before each application

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2006	Still on market

Device identification

Trade name: Nasenmanschette T-Gips - Marienhospital EM
UDI-DI code: 04250387102088
Basic UDI-DI: 42503871MANEMFP
Reference / catalog number: 15000021
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 15–17 MU10
23–25 MU10

EMDN nomenclature code(s)

M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES

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