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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

DF355 — Class IIa MDR by MEDICEM Technology s.r.o.

MD Atlas
MEDICEM Technology s.r.o.

EUDAMED last updated this device on Mar 25, 2026

DF355

085952317DF01A2

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MEDICEM Technology s.r.o.
UDI-DI code: 08595231703339
Reference / catalog number: DF355

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Manufacturer information

Organization name: MEDICEM Technology s.r.o.
SRN: CZ-MF-000000928
Manufacturer status: Active

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08595231703339
Basic UDI-DI: 085952317DF01A2
Reference / catalog number: DF355
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The DILASOFT is intended for use wherever cervical softening and dilation are desired, such as cervical ripening prior to labour induction, cervical preparation prior to termination of pregnancy or other instrumentation inside the uterine cavity.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U99DEVICES FOR UROGENITAL SYSTEM - 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

Related devices

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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.