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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

Nima Smart Gel Visco 45x45 cm — Class I MDR by Nimacare AB

MD Atlas
Nimacare AB

EUDAMED last updated this device on May 5, 2026

Nima Smart Gel Visco 45x45 cm

735005286SGVK4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Nimacare AB
UDI-DI code: 07333376001405
Reference / catalog number: SGV4545

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Manufacturer information

Organization name: Nimacare AB
SRN: SE-MF-000050989
Manufacturer status: Active

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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.

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement		Still on market

Device identification

Trade name: Nima Smart Gel Visco 45x45 cm
UDI-DI code: 07333376001405
Basic UDI-DI: 735005286SGVK4
Reference / catalog number: SGV4545
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: Visco elastic anatomically shaped foam base with Gel on the top layer
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 45 MU10
45 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

V08030102NON-ACTIVE ANTI-DECUBITUS MEDICAL CUSHIONS

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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