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Organization name
UDI-DI code
Reference / catalog number

92001151M — Class I MDR by Suomen Hoitolatukku…

MD Atlas
Suomen Hoitolatukku Tuonti Oy

EUDAMED last updated this device on Jan 2, 2022

92001151M

6416078FOOTTOEPROTEN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Suomen Hoitolatukku Tuonti Oy
UDI-DI code: 06416078011512
Reference / catalog number: 92001151M

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Manufacturer information

Organization name: Suomen Hoitolatukku Tuonti Oy
SRN: FI-MF-000011716
Manufacturer status: Active

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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.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Feb 1, 2022	Still on market

Device identification

Trade name: not provided
UDI-DI code: 06416078011512
Basic UDI-DI: 6416078FOOTTOEPROTEN
Reference / catalog number: 92001151M
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: Suoja vasaravarpaille ja nivelille, leikattavissa sopivan pituiseksi.
Additional information URL: https://www.hoitolatukku.fi/
Clinical sizes: Pituus 610 mm, sisähalkaisija 20 mm.

EMDN nomenclature code(s)

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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

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Software identification