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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

Ty&Já® Lubricant gel silicone — Class IIb MDR

MD Atlas
Dr. Müller Pharma s.r.o.

EUDAMED last updated this device on Mar 5, 2024

Ty&Já® Lubricant gel silicone

85956104LGS5W

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Müller Pharma s.r.o.
UDI-DI code: 08595610405991
Reference / catalog number: PC0253_001

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Manufacturer information

Organization name: Dr. Müller Pharma s.r.o.
SRN: CZ-MF-000000005
Manufacturer status: Active

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PC0203_01485956104LGGSOn the market PC8903_00285956104PSHWOn the market PC8901_00385956104PSHWOn the market ANGINAL® Oral Spray with Tea Tree Oil85956104PSHWOn the market PC8903_00185956104PSHWOn the market

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Czechia; available across 2 countries total.

Country	On market since	Until
CzechiaPrimary placement	Apr 9, 2019	Still on market
Slovakia	Apr 9, 2019	Still on market

Device identification

Trade name: Ty&Já® Lubricant gel silicone
UDI-DI code: 08595610405991
Basic UDI-DI: 85956104LGS5W
Reference / catalog number: PC0253_001
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

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

Certificates

Certificate health across this manufacturer's portfolio.

2023-MDR/QS-035/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-034/CSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-033/BSupplemented
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-031refdata.certificate-status.reissued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028
2023-MDR/QS-032Issued
Quality management systemNotified body: 2265Expiry: Oct 20, 2028

2023-MDR/QS-031

Issued

Quality management systemNotified body: 2265Expiry: Oct 20, 2028