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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

8260 — Class I MDR by spektramed GmbH

MD Atlas
spektramed GmbH

EUDAMED last updated this device on Dec 15, 2021

8260

425055662311010AW

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: spektramed GmbH
UDI-DI code: 04250556607475
Reference / catalog number: 8260

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Manufacturer information

Organization name: spektramed GmbH
SRN: DE-MF-000005711
Manufacturer status: Active

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		Still on market
Austria		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04250556607475
Basic UDI-DI: 425055662311010AW
Reference / catalog number: 8260
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 Stabilisierung des Beckens.
Additional information URL: https://ergoloc.de/#produkt
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y060303SACROILIAC 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

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.