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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

10-3535-K — Class I MDR by B.I.M.A. PLASTTEKNIK AB

MD Atlas
B.I.M.A. PLASTTEKNIK AB

EUDAMED last updated this device on Dec 10, 2025

10-3535-K

7340047310-SERIESW4

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: B.I.M.A. PLASTTEKNIK AB
UDI-DI code: 07340047300804
Reference / catalog number: 10-3535-K

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View device family (Basic UDI)

Manufacturer information

Organization name: B.I.M.A. PLASTTEKNIK AB
SRN: SE-MF-000001678
Manufacturer status: Active

Related devices

10-3535-PB-07340047300811On the market 40-5247-K73400473(C)40-SERIESVWOn the market 40-5243-P73400473(C)40-SERIESVWOn the market 40-5555-P73400473(C)40-SERIESVWOn the market 40-4750-K73400473(C)40-SERIESVWOn 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: not provided
UDI-DI code: 07340047300804
Basic UDI-DI: 7340047310-SERIESW4
Reference / catalog number: 10-3535-K
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: 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

EMDN nomenclature code(s)

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

V080399MEDICAL CUSHIONS - 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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