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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

37043 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

37043

B-DE-MF-000006543-37043U3

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-37043U3
Reference / catalog number: 37043

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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
Please do not use damaged or puncturedproducts. Keepout of reach of children. Do not use for more than 3 months after opening. Please do not share this Medical Device with other users. 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 product must be discontinued immediately.Please note that after the application of 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. Additional information: This product utilizes the cell-protectivemolecule Ectoin®-an ingredient with inflammation-reducingproperties. Ectoin®is a 100% natural ingredient obtained from microorganisms that live under extreme hostile environments (e.g. geysers, salt lakes, deserts). To protect themselves against the environmental stresses these microorganisms produce Ectoin®.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Apr 29, 2022	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-37043U3
Basic UDI-DI: B-DE-MF-000006543-37043U3
Reference / catalog number: 37043
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)

Q0399ENT DEVICES - 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