Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

Shaped vacuum leg splint TL125 — Class I MDR by Mediseam Oy

MD Atlas
Mediseam Oy

EUDAMED last updated this device on Apr 4, 2025

Shaped vacuum leg splint TL125

643006619TL1253Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Mediseam Oy
UDI-DI code: 06430066190997
Reference / catalog number: TL 125

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Mediseam Oy
SRN: FI-MF-000025545
Manufacturer status: Active

Related devices

TL 100 vacuum wrist/ankle splint643006619TL1003GOn the market TP 280 Compact vacuum mattress6430066190002809YOn the market TP 2800 Compact vacuum mattress set643006619002800ALOn the market TP 340 AS vacuum mattress6430066190003409ROn the market TP 3400 AS vacuum mattress set6430066193400VROn 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.

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: Shaped vacuum leg splint TL125
UDI-DI code: 06430066190997
Basic UDI-DI: 643006619TL1253Y
Reference / catalog number: TL 125
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: TL 125 shaped leg splint Dimensions: 100x65/50 cm, weight 1420 g Splint material is fibre reinforced, lacquered and durable, flame retardent pvc-fabric 3 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: 100 MU10
65 MU10
1420 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