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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

38129 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Aug 4, 2025

38129

B-38129H4

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-38129H4
Reference / catalog number: 38129

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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 device should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the eye drops. If allergic reactions occur, the use of the device must be discontinued immediately. To ensure safe hygiene, each eye drops bottle should only be used by one person. Do not use if the device is damaged or punctured. Do not use for more than 6 months after opening. The device should be kept out of reach of children.

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: D-38129H4
Basic UDI-DI: B-38129H4
Reference / catalog number: 38129
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: 10 MU03

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