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Organization name
UDI-DI code
Reference / catalog number

38128 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jan 9, 2026

38128

B-38128H2

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-38128H2
Reference / catalog number: 38128

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Manufacturer information

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

Critical warnings

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

CW999
The product should not be used in cases of hypersensitivity to Ectoin® or any of the other ingredients of the eye drops. If allergic reactions occur due to the product, use of the product must be discontinued immediately. Please do not use damaged or punctured products. To ensure proper hygiene, each eye drop bottle should only be used by one person. Do not use the product for more than three months after opening. The product should be kept out of the reach of children. If recommended by a doctor or healthcare professional, the product may be used after eye/ocular surgery or trauma. When used within its intended purpose, there is no evidence of a particular risk associated with the use of the product during pregnancy or breastfeeding. Children 10 years of age and younger, as well as patients who are unable to use the product on their own, should be assisted during application. The product is suitable for children.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Jan 31, 2026	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-38128H2
Basic UDI-DI: B-38128H2
Reference / catalog number: 38128
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: Ectoin® Allergy Eye Drops 2% are eye drops for the treatment and prevention of allergic conjunctivitis symptoms.
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

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Certificates

Certificate health across this manufacturer's portfolio.

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