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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

38022 — Class IIa MDR by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

38022

426026522ANS3KZG

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: bitop AG
UDI-DI code: 04260265220100
Reference / catalog number: 38022

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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:: If allergic reactions occur, the use of the Product must be discontinued immediately. Do not use the device if it is damaged or punctured. To ensure safe hygiene, each nasal spray bottle is to be used by one person only. Do not use for more than 3 months after opening. Do not use after expiry date. Keep out of reach of children. Additional information If the Product is used within its intended use, there is no evidence for a particular risk during pregnancy and breast-feeding. Should any serious incident related to the Product occur, please report it to the legal manufacturer of the product at vigilance@bitop.de and the responsible local competent authority. Please insert name of responsible local competent authority.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 8, 2025	May 8, 2099

Device identification

Trade name: not provided
UDI-DI code: 04260265220100
Basic UDI-DI: 426026522ANS3KZG
Reference / catalog number: 38022
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 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