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Organization name
UDI-DI code
Reference / catalog number

ABC Bacterial Vaginosis 5x7 ml — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on May 3, 2026

ABC Bacterial Vaginosis 5x7 ml

B-954854SW

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-954854SW
Reference / catalog number: 954854

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View device family (Basic UDI)

Manufacturer information

Organization name: PK Benelux BV
SRN: NL-MF-000006672
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: • Keep out of reach of young children; • If you experience allergic reactions stop using the product. Possible side effects: Lactic acid is safe and tolerable. Common side effects are vaginal symptoms such as itching and/or a burning sensation. Use during pregnancy and/or breastfeeding: As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Do not use Bacterial vaginosis: If you are hypersensitive to one or more of the ingredients.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Mar 3, 2023	Still on market

Device identification

Trade name: ABC Bacterial Vaginosis 5x7 ml
UDI-DI code: D-954854SW
Basic UDI-DI: B-954854SW
Reference / catalog number: 954854
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: To treat and prevent bacterial vaginosis and restoring the acidity and the balance of the vaginal flora.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-954854SW

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

U0803VAGINAL DEVICES IN THE FORM OF SOLUTIONS/CREAMS/OVA/TABLETS

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

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