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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

SA204 — Class IIa MDR by Auditdata A/S

MD Atlas
Auditdata A/S

EUDAMED last updated this device on May 28, 2024

SA204

05711781DHF2009ZW

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Auditdata A/S
UDI-DI code: 05711781001258
Reference / catalog number: SA204

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View device family (Basic UDI)

Manufacturer information

Organization name: Auditdata A/S
SRN: DK-MF-000011415
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Denmark; available across 1 country total.

Country	On market since	Until
DenmarkPrimary placement	Dec 29, 1995	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05711781001258
Basic UDI-DI: 05711781DHF2009ZW
Reference / catalog number: SA204
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: —
Additional information URL: https://support.auditdata.com/portal/en/kb/
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05711781001258

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Z121401AUDIOMETERS

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

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Related devices

90.303005711781DHF2000ZCOn the market 90.302905711781DHF2000ZCOn the market 2003 Auditbase05711781DHF2003-12ZOn the market SA20105711781DHF2009ZWOn the market SA20205711781DHF2009ZWOn 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.