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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

454000 — Class IIa MDD by Schaefers Medizintechnik…

MD Atlas
Schaefers Medizintechnik GmbH

EUDAMED last updated this device on Jan 28, 2023

454000

B-111825114530

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Schaefers Medizintechnik GmbH
UDI-DI code: 111825114530
Reference / catalog number: 454000

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Manufacturer information

Organization name: Schaefers Medizintechnik GmbH
SRN: DE-MF-000006991
Manufacturer status: Active

Critical warnings

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

CW018
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Oct 1, 2021	Still on market

Device identification

Trade name: not provided
UDI-DI code: 111825114530
Basic UDI-DI: B-111825114530
Reference / catalog number: 454000
Issuing entity: IFA

Classification

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

Device details

Quantity: 1
Additional product description: http://www.schaefers-medizintechnik.de/downloads/Gebrauchsanweisung%20irrimed%20classic%20454000%202022-06-12%20DK.PDF
Additional information URL: http://www.schaefers-medizintechnik.de/downloads/Gebrauchsanweisung%20irrimed%20classic%20454000%202022-06-12%20DK.PDF
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A03010299IRRIGATION CONTROLLERS - 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

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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.