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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

36011 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Feb 17, 2026

36011

B-DE-MF-000006543-36011TF

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-36011TF
Reference / catalog number: 36011

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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 device should not be used in case of hypersensitivity to Ectoin® or any of the other ingredients of the nasal spray. •If allergic reactions occur, the use of the device must be discontinued immediately. •Do not use if the device is damaged or punctured. •To ensure safe hygiene, each nasal spray bottle should only be used by one person. •Do not use for more than 3 months after opening. •The device should be kept out of reach of children

Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-36011TF
Basic UDI-DI: B-DE-MF-000006543-36011TF
Reference / catalog number: 36011
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

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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.