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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 30x30 cm — Class I MDR by Nimacare AB

MD Atlas
Nimacare AB

EUDAMED last updated this device on May 5, 2026

Nima Smart Gel Visco 30x30 cm

735005286SGVK4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Nimacare AB
UDI-DI code: 07333376018939
Reference / catalog number: SGV3030

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Manufacturer information

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

Critical warnings

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

CW010
The device must be used in accordance with the instructions for use. Incorrect use or positioning may increase the risk of pressure injury

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Market distribution

Primary placement in Sweden; available across 1 country total.

Country	On market since	Until
SwedenPrimary placement	May 5, 2026	Still on market

Device identification

Trade name: Nima Smart Gel Visco 30x30 cm
UDI-DI code: 07333376018939
Basic UDI-DI: 735005286SGVK4
Reference / catalog number: SGV3030
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: 30 MU10
30 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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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.