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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

30461 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

30461

B-DE-MF-000006543-30461T8

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-30461T8
Reference / catalog number: 30461

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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 after nasal operationsorinjuries of the nose.•the Product should not be used in the case of hypersensitivity to Ectoin®or any of the other ingredients of the nasal spray.•If allergic reactions occur, the use of the Product must be discontinued immediately.•To ensure safe hygiene,each nasal spray bottle shouldonly be used by one person.•Do not use for more than 6 weeks after opening.•the Product should be kept out of reach of children. Additional information Currently, there are no data available regarding the use of the Product during pregnancy and while breast-feeding. Consult your healthcare provider or pharmacist for advice, before using this Medical Device, if you are:•pregnant or breast-feeding •not sure whether you are pregnant or not 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.

Market distribution

Primary placement in Poland; available across 1 country total.

Country	On market since	Until
PolandPrimary placement	Jul 19, 2024	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-30461T8
Basic UDI-DI: B-DE-MF-000006543-30461T8
Reference / catalog number: 30461
Issuing entity: EUDAMED

Classification

Risk category: Class I
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