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Organization name
UDI-DI code
Reference / catalog number

42014400L — Class IIa MDD by Penta Arzneimittel GmbH

MD Atlas
Penta Arzneimittel GmbH

EUDAMED last updated this device on May 27, 2026

42014400L

B-04260595530405

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Penta Arzneimittel GmbH
UDI-DI code: 04260595530405
Reference / catalog number: 42014400L

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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 the safety ring of the tamper evident closure is broken or the bottle is damaged.
CW032
Do not use the eye drops beyond the expiry date which you can find on each multi-dose container and on the folding box. Use the irrigation solution immediately after opening the bottle for the first time.
CW010
Consult instructions for use.
CW036
Do not add any other substances.
CW008
Do not touch the eye with the dropper.
CW129
Do not use in patients with a hypersensitivity to any of the ingredients.
CW011
Do not use for injection or infusion. In diabetic patients undergoing vitrectomy, caution should be taken when using Physiological Eye Irrigation Solution (BSS) due to the possibility of intraoperative lens changes caused by the hyperosmolality of the aqueous humour in these patients.
CW020
Do not resterilise.

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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: 04260595530405
Basic UDI-DI: B-04260595530405
Reference / catalog number: 42014400L
Issuing entity: GS1

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: The Physiological Eye Irrigation Solution (BSS, 15ml) maintains the pH and osmotic balance of the eye tissue during surgical procedures as well as during diagnostic or therapeutic measures.
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)04260595530405

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EMDN nomenclature code(s)

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

Q02030203OPHTHALMIC SURGERY BALANCED SALINE SOLUTIONS

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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