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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

30769 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jan 20, 2026

30769

B-DE-MF-000006543-30769U7

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-30769U7
Reference / catalog number: 30769

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Manufacturer information

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

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
•Do not be used on infected skin. •Keep out of reach of children. •Do not use for more than 6 months after opening. •The cream should not be used in the case of hypersensitivity to Ectoin® or any of the other ingredients of the cream. If allergic reactions occur, discontinue use immediately. •Product should only be used by one person. •Product should be only used for topical application on skin.

Market distribution

Primary placement in Slovakia; available across 1 country total.

Country	On market since	Until
SlovakiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-30769U7
Basic UDI-DI: B-DE-MF-000006543-30769U7
Reference / catalog number: 30769
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
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)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

Related devices

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Certificates

Certificate health across this manufacturer's portfolio.

HZ 1342003-1Supplemented
Quality management systemNotified body: 0197Expiry: Feb 26, 2029