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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Ectoin® Eye Gel Drops — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 11, 2026

Ectoin® Eye Gel Drops

B-DE-MF-000006543-30741TH

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-30741TH
Reference / catalog number: 30741

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Manufacturer information

Organization name: bitop AG
SRN: DE-MF-000006543
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

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

CW999
•Product should not be used in the case of hypersensitivity to Ectoin®or any of the other ingredients of the eye drops.•If allergic reactions due to the product occur, the use of the product must be discontinued immediately.•Please do not use damaged or punctured products.•To ensure safe hygiene,each eye dropbottle should only be used by one person.•Do not use for more than 3 months after opening.•Product should be kept out of reach of children.•Please note that after the application of the product your vision may be impaired temporarily. In this case no vehicle should be driven and no machines operated. Therefore, it is recommended to wait until normal visual acuity has returned.

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: Ectoin® Eye Gel Drops
UDI-DI code: D-DE-MF-000006543-30741TH
Basic UDI-DI: B-DE-MF-000006543-30741TH
Reference / catalog number: 30741
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)

Q02030299OPHTHALMOLOGY, LIQUID FLUIDS - 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