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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

AC 77 — Class I MDR by Ondal Medical Systems…

MD Atlas
Ondal Medical Systems GmbH

EUDAMED last updated this device on Oct 27, 2021

AC 77

4061591000400QX

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ondal Medical Systems GmbH
UDI-DI code: 04061591000011
Reference / catalog number: AC 77

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Manufacturer information

Organization name: Ondal Medical Systems GmbH
SRN: DE-MF-000000203
Manufacturer status: Active

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MediHoist4061591000424RDOn the market AC 20004061591000400QXOn the market AC 30004061591000417RGOn the market AC LCH4061591000400QXOn the market AC Swing4061591000400QXOn 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.

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: 04061591000011
Basic UDI-DI: 4061591000400QX
Reference / catalog number: AC 77
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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