EUDAMED last updated this device on Dec 17, 2025

BIMA

B-07340047300811

On the marketClass I

Applicable legislation: —
Organization name: B.I.M.A. PLASTTEKNIK AB
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 07340047300811
Reference / catalog number: 10-3535-P

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

BIMA is an EU-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by B.I.M.A. PLASTTEKNIK AB. Placed on the EU market in Sweden. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: BIMA
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 07340047300811
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-07340047300811
Reference / catalog number: 10-3535-P
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: Class I
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: Steady, comfortable, and pressure-distributing wheelchair cushion, intended for people who are dependent on a wheelchair for their movements but can vary their sitting. Remedy for low risk of pressure ulcers. The cushion base is incontinence-proof, the cover is airy and comfortable. Bima basic recond is used when there is a high risk of incontinence. And then the cushion can be reconditioned to new condition.
Additional information URL: https://bimasweden.se/produkter/bima-basic-recond/
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)07340047300811

EMDN nomenclature code(s)

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

V080399MEDICAL CUSHIONS - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Sweden; available across 1 country total.

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

BIMA

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UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

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Market distribution

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Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

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Safety

Regulatory

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Certificates

Certificates covering this device

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Certificates

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