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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

100024301 — Class I MDR by spektramed GmbH

MD Atlas
spektramed GmbH

EUDAMED last updated this device on Jul 25, 2022

100024301

425055662314041BW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: spektramed GmbH
UDI-DI code: 04250556605129
Reference / catalog number: 100024301

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Manufacturer information

Organization name: spektramed GmbH
SRN: DE-MF-000005711
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

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

CW030
EUDAMED did not publish a description for this code.
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 2 countries total.

Country	On market since	Until
GermanyPrimary placement	Jan 1, 2014	Still on market
Austria	Jan 1, 2023	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250556605129
Basic UDI-DI: 425055662314041BW
Reference / catalog number: 100024301
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: Orthese zur Entlordosierung, Entlastung und funktionellen Mobilisierung der Wirbelsäule in Frontal- und Sagittalebene. Versorgungsbereich: TH11 – L5.
Additional information URL: https://www.spektramed.de/produkte/rumpf/ergopro-entlordosierend
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060309THORACOLUMBOSACRAL SPINE ORTHOSES

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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Manufacturing date
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Software identification