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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

38100 — Class IIa MDR by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jul 8, 2025

38100

426026522SNS013K9Y

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: bitop AG
UDI-DI code: 04260265220735
Reference / catalog number: 38100

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Manufacturer information

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

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
Must not be used in the case of hypersensitivity to medEctoin® or any of the other ingredients of the device. Must not be used for patients below 3,5 kg bodyweight. 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. If conditions persist or worsen, contact your healthcare provider. If you have applied a higher amount of the product than you should, no negative effects are expected. If you are experiencing discomfort, please contact a doctor.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260265220735
Basic UDI-DI: 426026522SNS013K9Y
Reference / catalog number: 38100
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: 20 MU03

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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