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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

38132 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jul 16, 2025

38132

B-38132GR

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-38132GR
Reference / catalog number: 38132

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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
Should not be used during persisting traumas, e. g. after surgery or injuries of the mouth. 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 the product must be discontinued immediately. Children younger than 6 years should not use the 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. Should be kept out of reach of children.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-38132GR
Basic UDI-DI: B-38132GR
Reference / catalog number: 38132
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: 16 Lozenges with a weigth of 2.3 gram per Lozenge

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
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Software identification