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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

163.008 — Class I MDR by SISSEL GmbH

MD Atlas
SISSEL GmbH

EUDAMED last updated this device on Apr 27, 2023

163.008

42506947Y0504CS

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: SISSEL GmbH
UDI-DI code: 04250694702841
Reference / catalog number: 163.008

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Manufacturer information

Organization name: SISSEL GmbH
SRN: DE-MF-000007624
Manufacturer status: Active

Related devices

160.00842506947Z1206023ROn the market 110.00442506947V0803022TOn the market 110.00542506947V0803022TOn the market 110.00142506947V0803022TOn the market 110.01942506947V0803022TOn 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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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: 04250694702841
Basic UDI-DI: 42506947Y0504CS
Reference / catalog number: 163.008
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)

Y0504ARMS, TORSO AND LEGS RE-EDUCATION DEVICES

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
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Software identification