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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

4160 / 4162 / 4175 / 4180 — Class I MDR by Sairex Oy

MD Atlas
Sairex Oy

EUDAMED last updated this device on Mar 12, 2024

4160 / 4162 / 4175 / 4180

642981076804160PR

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sairex Oy
UDI-DI code: 06429810768469
Reference / catalog number: 4160 / 4162 / 4175 / 4180

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Manufacturer information

Organization name: Sairex Oy
SRN: FI-MF-000039541
Manufacturer status: Active

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 06429810768469
Basic UDI-DI: 642981076804160PR
Reference / catalog number: 4160 / 4162 / 4175 / 4180
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: Erityismuotoiltu, kangaspäällinen tuote vuodepotilaan nilkan, kantapään tai käsivarren ympärille tai käteen. Ehkäisee hankaumien, makuuhaavojen ja painumavammojen syntyä. Jalan tai käden esteetön liikuttelu kuitenkin mahdollinen. Ei-steriili tuote yhdelle potilaalle lyhyt- tai pitkäaikaiseen käyttöön.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V0811HEEL, ELBOW AND KNEE ANTI-DECUBITUS PROTECTION AIDS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

4265 / 4267 / 4229 / 4235642981076804265Q8On the market 3187a / 3188a / 3189a /3190a64298107683187XNOn the market 1565/1566/1566X642981076801565Q2On the market 420164298107684201WWOn the market 4110 / 4120 / 4115 / 4128 / 4126 / 4127642981076804110PAOn 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.