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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

S2SFam — Class I MDR by Neolook Solutions

MD Atlas
Neolook Solutions

EUDAMED last updated this device on Aug 9, 2024

S2SFam

87202999477S2SAA

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Neolook Solutions
UDI-DI code: 08720299947702
Reference / catalog number: S2SFam

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View device family (Basic UDI)

Manufacturer information

Organization name: Neolook Solutions
SRN: NL-MF-000028851
Manufacturer status: Active

Critical warnings

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

CW010
Contra-indications are described in the IFIU

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Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	Aug 8, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08720299947702
Basic UDI-DI: 87202999477S2SAA
Reference / catalog number: S2SFam
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: Software as a Medical Device using livestreams and video technology with intended purpose for Bonding and Parent Participation.
Additional information URL: No additional information URL provided by the manufacturer.
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)08720299947702

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EMDN nomenclature code(s)

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

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

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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.