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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

V2 — Class I MDR by VARILAG GmbH & Co. KG

MD Atlas
VARILAG GmbH & Co. KG

EUDAMED last updated this device on Dec 15, 2021

V2

PP11846SLS28

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VARILAG GmbH & Co. KG
UDI-DI code: 111752871616
Reference / catalog number: V2

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Manufacturer information

Organization name: VARILAG GmbH & Co. KG
SRN: DE-MF-000005987
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.

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: 111752871616
Basic UDI-DI: PP11846SLS28
Reference / catalog number: V2
Issuing entity: IFA

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: Seitenlagerungsschiene für Säuglinge bestehend aus zwei Keilen mit Rumpfgurt, Fixierbändern und Gebrauchsanweisung.
Additional information URL: https://www.varilag.de/lagerungskissen-baby/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0299NEONATOLOGY AND PAEDIATRIC DEVICES - 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

Related devices

This device is not currently linked to any other device.

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.