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Organization name
UDI-DI code
Reference / catalog number

LiMAx breathing mask — Class IIa MDD by Humedics GmbH

MD Atlas
Humedics GmbH

EUDAMED last updated this device on Jun 29, 2023

LiMAx breathing mask

B-MDD-BreathingMaskKZ

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Humedics GmbH
UDI-DI code: D-MDD-BreathingMaskKZ
Reference / catalog number: 201002

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Manufacturer information

Organization name: Humedics GmbH
SRN: DE-MF-000005094
Manufacturer status: Active

Critical warnings

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

CW011
The breathing mask is made of latex-free silicone rubber. This material is used as standard in clinical settings because of its high level of safety when coming into contact with patients. Nevertheless, in a small number of cases patients may display silicone intolerance when the breathing mask is used. In such cases, special precautionary measures, such as the application of a protective gel (e.g. hydrocolloid dressings) between the mask and the patient’s face, may be required in order to perform the LiMAx test.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 3 countries total.

Country	On market since	Until
GermanyPrimary placement		Still on market
Austria		Still on market
Bulgaria		Still on market

Device identification

Trade name: LiMAx breathing mask
UDI-DI code: D-MDD-BreathingMaskKZ
Basic UDI-DI: B-MDD-BreathingMaskKZ
Reference / catalog number: 201002
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC 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: No clinical sizes registered for this device.

EMDN nomenclature code(s)

R030199RESPIRATORY MASKS - 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

Related devices

FLIP4.0B-MDD-FLIP4.0Z8On the market LiMAx Breathing Mask Set A912008761HUM100088On the market LiMAx Breathing Mask Set B912008761HUM100088On the market LiMAx Measuring Device912008761HUM01408JOn 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.