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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

38163 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 11, 2026

38163

B-DE-MF-000006543-38163UM

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38163UM
Reference / catalog number: 38163

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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
Product should not be used during persisting traumas, e. g. after surgery or injuries of the mouth. Product should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the lozenges. If allergic reactions occur, the use of product must be discontinued immediately. Children younger than 6 years should not use product due to danger of suffocation. Do not use the lozenges while lying down, e.g. at bedtime, due to the risk of choking. Do not use lozenges from damaged or punctured blisters. Product should be kept out of reach of children. Additional information: Currently, there are no data available regarding the use of 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

Market distribution

Primary placement in EL; available across 2 countries total.

Country	On market since	Until
ELPrimary placement		Still on market
Cyprus		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-38163UM
Basic UDI-DI: B-DE-MF-000006543-38163UM
Reference / catalog number: 38163
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