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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

38070 — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

38070

B-DE-MF-000006543-38070UD

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38070UD
Reference / catalog number: 38070

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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
If allergic reactions occur, discontinue use immediately. Do not use damaged products. Before each application, the applicator must be carefully checked for its integrity. Do not use the applicator, if it is damaged (e.g. has visible cracks or chips) or its plunger is loosened and disassembles from the tube easily. To ensure safe hygiene, this product should only be used by one person. Do not use for more than 3 months after opening. Keep out of reach of children. If conditions persist or worsen, or if signs of infection (as a vaginal discharge of an unusual colour/consistency/odour) occur, contact your healthcare provider or pharmacist. The product is neither spermicide, nor supporting conception. The product does not protect against sexually transmitted diseases. The product has no contraceptive action and cannot be used to prevent pregnancy. Product should not be used in case of hypersensitivity to Ectoin®, Propylene Glycol or any of the other ingredients of the gel. Do not use in case of traumas or surgeries in the vaginal area. Do not use during vulvovaginal infections. Do not use the intravaginal applicator during pregnancy. Not all minor constituents of the product have been extensively investigated for safety during pregnancy and breast-feeding. In the absence of sufficient data, the use of the product during pregnancy and while breast-feeding is not recommended. Patients unable to use the product on their own should be assisted during the application the product. The product is intended for use in adults.

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: D-DE-MF-000006543-38070UD
Basic UDI-DI: B-DE-MF-000006543-38070UD
Reference / catalog number: 38070
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)

U0899GYNAECOLOGICAL 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