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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

Combi belt M — Class I MDR by Careva System AB

MD Atlas
Careva System AB

EUDAMED last updated this device on Oct 18, 2024

Combi belt M

7350037450018U

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Careva System AB
UDI-DI code: 07350037450235
Reference / catalog number: 10224 M

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View device family (Basic UDI)

Manufacturer information

Organization name: Careva System AB
SRN: SE-MF-000004861
Manufacturer status: Active

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Buckle Extra long7350037450018UOn the market Buckle Extra long7350037450018UOn the market Careva Combi KIT7350037450018UOn the market Careva Combi KIT7350037450018UOn the market Careva Combi KIT7350037450018UOn 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

No critical warnings reported for this device.

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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: Combi belt M
UDI-DI code: 07350037450235
Basic UDI-DI: 7350037450018U
Reference / catalog number: 10224 M
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: The Combi belt provides the person with support and/or fixation for an upright sitting position. The belt fixes both the shoulders and the pelvis. Always be combined with Spinal belt 10285 and buckle 10040.
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)07350037450235

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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.

Y180980SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES

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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