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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

MED1002646-B — Class I MDR by medesign I.C. GmbH

MD Atlas
medesign I.C. GmbH

EUDAMED last updated this device on Jan 27, 2025

MED1002646-B

425020122639ZU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: medesign I.C. GmbH
UDI-DI code: 04250201226396
Reference / catalog number: MED1002646-B

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Manufacturer information

Organization name: medesign I.C. GmbH
SRN: DE-MF-000020677
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW262
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 04250201226396
Basic UDI-DI: 425020122639ZU
Reference / catalog number: MED1002646-B
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Zur konservativen Therapie in der Gynäkologie, z.B. bei Verengung des Scheideneingangs und des vaginalen Bereichs (Vulva und Vagina) zur Vermeidung einer entsprechenden Operation.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0509020101VAGINAL DILATORS, REUSABLE

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

MED1001738-B425020122672ZSOn the market MED1001739-B42502012266826On the market MED1001416-B425020122673ZUOn the market MED1001740-B42502012267727On the market MED1001741-B42502012267829On the market

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.