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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

39966 — Class IIa MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on Jan 23, 2026

39966

B-DE-MF-000006543-39966WA

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-39966WA
Reference / catalog number: 39966

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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
Do not use 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. Currently, there are no data available regarding the use of the 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 or not sure whether you are pregnant or not.

Market distribution

Primary placement in Sweden; available across 3 countries total.

Country	On market since	Until
SwedenPrimary placement		Still on market
Denmark		Still on market
Finland		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-39966WA
Basic UDI-DI: B-DE-MF-000006543-39966WA
Reference / catalog number: 39966
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