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Organization name
UDI-DI code
Reference / catalog number

CanesMeno Hydration & Comfort Gel — Class I MDD by bitop AG

MD Atlas
bitop AG

EUDAMED last updated this device on May 19, 2026

CanesMeno Hydration & Comfort Gel

B-DE-MF-000006543-38030TZ

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: bitop AG
UDI-DI code: D-DE-MF-000006543-38030TZ
Reference / catalog number: 38030

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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
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.

Market distribution

Primary placement in Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: CanesMeno Hydration & Comfort Gel
UDI-DI code: D-DE-MF-000006543-38030TZ
Basic UDI-DI: B-DE-MF-000006543-38030TZ
Reference / catalog number: 38030
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
Serial number
Software identification

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Certificates

Certificate health across this manufacturer's portfolio.

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