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Organization name
UDI-DI code
Reference / catalog number

Z1009 — Class IIb MDR by Cosmonde, a.s.

MD Atlas
Cosmonde, a.s.

EUDAMED last updated this device on Mar 18, 2026

Z1009

85950039CM005J9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Cosmonde, a.s.
UDI-DI code: 08595003904773
Reference / catalog number: Z1009

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Manufacturer information

Organization name: Cosmonde, a.s.
SRN: CZ-MF-000029535
Manufacturer status: Active

Critical warnings

8 warnings recorded — scroll inside the panel to see all entries.

CW011
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
If you are pregnant or breastfeeding, consult a physician before use. Do not use during menstruation. Do not use for other than the intended purposes. It is not a contraceptive and does not contain a spermicidal component. May affect sperm motility. Avoid contact with eyes, damaged or inflamed skin or mucous membranes. If the instructions in the Instructions for Use are not followed, there is a risk of reduced effectiveness or contamination of the lubricating gel and subsequent irritation or allergic reactions. If these symptoms occur, rinse with water and stop using the lubricant.
CW277
If irritation persists, seek medical attention.
CW276
Do not use concomitantly with any other topical gynaecological treatment without first consulting a doctor.
CW036
Use only with a latex condom.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Apr 1, 2026	Still on market
Slovakia	Apr 1, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595003904773
Basic UDI-DI: 85950039CM005J9
Reference / catalog number: Z1009
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: A medical device intended to supplement or replace the natural vaginal lubricating fluid produced during female sexual arousal. It eliminates the discomfort of vaginal dryness that can occur with a lack of or insufficient natural lubrication
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU48

EMDN nomenclature code(s)

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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

Related devices

Z100085950039CM001HZOn the market Z100185950039CM001HZOn the market Z100885950039CM004J7On the market Z100385950039CM002J3On the market Z100485950039CM002J3On the market

Certificates

Certificate health across this manufacturer's portfolio.

2025-MDR/QS-029/AIssued
Quality management systemNotified body: 2265Expiry: May 13, 2030
2025-MDR/QS-030/AIssued
Quality management systemNotified body: 2265Expiry: May 13, 2030