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Organization name
UDI-DI code
Reference / catalog number

30889 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Dec 1, 2025

30889

B-DE-MF-000006543-30889UJ

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-30889UJ
Reference / catalog number: 30889

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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 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. • Do not use on infected skin. • To ensure safe hygiene, this product should only be used by one person. • The Product should only be used for topical application on skin. • Keep out of reach of children. • Do not use for more than 3 months after opening. Additional information Not all minor constituents of the Product have been extensively investigated for safety during pregnancy and while breast-feeding. In the absence of sufficient data, the use of the Product during pregnancy and while breast-feeding is not recommended. The Product is suitable for long-term treatment or daily use. It is free of dyes, fragrances, preservatives, mineral oils, parabens and emulsifiers. The Product is a fast absorbing and non greasy cream. The Product is suitable for infants and children. Children and patients unable to use the Product on their own should be assisted during application of the Product.

Market distribution

Primary placement in Poland; available across 2 countries total.

Country	On market since	Until
PolandPrimary placement		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-30889UJ
Basic UDI-DI: B-DE-MF-000006543-30889UJ
Reference / catalog number: 30889
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