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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

39904 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Aug 14, 2025

39904

B-DEMF000006543-39904WN

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DEMF000006543-39904WN
Reference / catalog number: 39904

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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 in 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. 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 product should be kept out of reach of children. Additional information: If the product is applied within its intended use, there is no evidence for a particular risk during pregnancy or breast-feeding. The product is suitable for children. 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 Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-DEMF000006543-39904WN
Basic UDI-DI: B-DEMF000006543-39904WN
Reference / catalog number: 39904
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: 20 mL solutionOne spray contains 0.14 mL solution

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