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Organization name
UDI-DI code
Reference / catalog number

Safety belt HAR1 — Class I MDR by Suomen Laitostekstiilit…

MD Atlas
Suomen Laitostekstiilit Ky

EUDAMED last updated this device on Dec 12, 2021

Safety belt HAR1

643007748HAR199

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suomen Laitostekstiilit Ky
UDI-DI code: 06430077480032
Reference / catalog number: HAR1

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Manufacturer information

Organization name: Suomen Laitostekstiilit Ky
SRN: FI-MF-000002842
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: Safety belt HAR1
UDI-DI code: 06430077480032
Basic UDI-DI: 643007748HAR199
Reference / catalog number: HAR1
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: T-shaped safety belt prevents patient from falling for example from wheel chair.
Additional information URL: https://www.suomenlaitostekstiilit.com/haaravy%C3%B6
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Y090699DEVICES FOR BODY PROTECTION - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Rescue sheet EL-2A643007748EL2A90YYOn 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.