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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

38158 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Feb 4, 2026

38158

B-DE-MF-000006543-38158UU

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38158UU
Reference / catalog number: 38158

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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
Warnings and precautions • the 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 drop bottle should only be used by one person. • Do not use for more than 3 months after opening. • the Product should be kept out of reach of children. Additional information If recommended by your doctor or health care professional, the Product may be used after eye or ocular surgery and trauma. If the Product is applied within its intended use, there is no evidence for a particular risk during pregnancy or breast feeding. Children 10 years of age and younger and patients unable to use the Product on their own should be assisted during the application of the Product. Suitable for children.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Apr 2, 2026	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-38158UU
Basic UDI-DI: B-DE-MF-000006543-38158UU
Reference / catalog number: 38158
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