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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

33027 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jan 7, 2026

33027

B-DE-MF-000006543-33027T9

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-33027T9
Reference / catalog number: 33027

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Manufacturer information

Organization name: bitop AG
SRN: DE-MF-000006543
Manufacturer status: Active

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Critical warnings

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

CW999
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 drop bottle should only be used by one person. Do not use for more than 3 months after opening. 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 Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-33027T9
Basic UDI-DI: B-DE-MF-000006543-33027T9
Reference / catalog number: 33027
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

Certificates

Certificate health across this manufacturer's portfolio.

HZ 1342003-1Supplemented
Quality management systemNotified body: 0197Expiry: Feb 26, 2029