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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

TL 100 vacuum wrist/ankle splint — Class I MDR by Mediseam Oy

MD Atlas
Mediseam Oy

EUDAMED last updated this device on Apr 4, 2025

TL 100 vacuum wrist/ankle splint

643006619TL1003G

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mediseam Oy
UDI-DI code: 06430066190966
Reference / catalog number: TL 100

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Manufacturer information

Organization name: Mediseam Oy
SRN: FI-MF-000025545
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: TL 100 vacuum wrist/ankle splint
UDI-DI code: 06430066190966
Basic UDI-DI: 643006619TL1003G
Reference / catalog number: TL 100
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: TL100 vacuum splint (children´s arm or adult´s ankle/wrist) Dimensions: 50×45/40cm, weight 490 g Splint´s material is fibre reinforced, lacquered and durable, flame retardent pvc-fabric 2 linkage belts with plastic locks Pistol valve, PLCD17004 Filling consists of hard, fire retardant plastic micro pellets Finnish Key Flag -product
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU10
40 MU10
490 MU24

EMDN nomenclature code(s)

M03050299BANDAGES AND SPLINTS - 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

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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.