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Organization name
UDI-DI code
Reference / catalog number

41110700 — Class IIb MDR by Penta Arzneimittel GmbH

MD Atlas
Penta Arzneimittel GmbH

EUDAMED last updated this device on May 29, 2026

41110700

426059553MP29UD01MA

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Penta Arzneimittel GmbH
UDI-DI code: 14260595530303
Reference / catalog number: 41110700

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View device family (Basic UDI)

Manufacturer information

Organization name: Penta Arzneimittel GmbH
SRN: DE-MF-000006565
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

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

CW007
Do not use the product if single dose container is damaged.
CW032
Do not use the inhalation solution beyond the expiry date which you can find on each single dose container and on each folding box.
CW010
Consult instructions for use.
CW036
Do not use Sodium Chloride 6% Inhalation Solution with medicines for inhalation without consulting your doctor.
CW135
The eye drops are filled into small plastic containers which could be swallowed by small children. Therefore, please keep the product out of the reach of children. Do not allow children to inhale unsupervised.
CW011
Do not use for injection. Do not use if there is a risk of respiratory distress. In individual cases, temporary irritation (e.g. coughing) or a re-sensitive constriction of the bronchial tubes may occur.
CW129
Do not use if you are allergic to any of the ingredients.
CW277
In case a serious incident has occurred during the use of this medical device or as a result of its use, please report it to the manufacturer and the competent authority.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 14260595530303
Basic UDI-DI: 426059553MP29UD01MA
Reference / catalog number: 41110700
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: Sodium Chloride 6% Inhalation Solution (single dose container, 4ml) liquifies viscous mucus in the lower respiratory tract by restoring the osmotic balance in the cells.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)14260595530303

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

R060203INHALATION THERAPY HUMIDIFICATION LIQUIDS

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

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