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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

Fiber Collar Large 2.0 kg — Class I MDR by Novista of Sweden AB

MD Atlas
Novista of Sweden AB

EUDAMED last updated this device on Mar 2, 2026

Fiber Collar Large 2.0 kg

735008131C6R

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Novista of Sweden AB
UDI-DI code: 07350081311278
Reference / catalog number: 735008131C6R

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View device family (Basic UDI)

Manufacturer information

Organization name: Novista of Sweden AB
SRN: SE-MF-000045071
Manufacturer status: Active

Related devices

Fiber Collar Medium 1.5 kg735008131C6ROn the market Fiber Collar Small 1.0 kg735008131C6ROn the market Futura 10 kg735008131F6XOn the market Futura 12 kg735008131F6XOn the market Futura 14 kg735008131F6XOn 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.

CW999
Do not use the collar while lying down, especially with pressure on the neck. Always wear it with the opening facing forward and clear of the throat — never turned backward. Do not heat the collar in any way.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Device identification

Trade name: Fiber Collar Large 2.0 kg
UDI-DI code: 07350081311278
Basic UDI-DI: 735008131C6R
Reference / catalog number: 735008131C6R
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07350081311278

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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