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Organization name
UDI-DI code
Reference / catalog number

MED1000063 — Class IIb MDD by medesign I.C. GmbH

MD Atlas
medesign I.C. GmbH

EUDAMED last updated this device on May 6, 2024

MED1000063

B-04250201201546

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: medesign I.C. GmbH
UDI-DI code: 04250201201546
Reference / catalog number: MED1000063

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Manufacturer information

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

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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.

Critical warnings

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

CW010
Gebrauchsanweisung lesen

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2000	May 6, 2024

Device identification

Trade name: not provided
UDI-DI code: 04250201201546
Basic UDI-DI: B-04250201201546
Reference / catalog number: MED1000063
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Behandlungseinheit Pessar und Gleitgel
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U089005PESSARIANS

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

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Software identification