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

TT-Painopeitto Pro Helmi Baby 2kg — Class I MDR by TikkiTeam Oy

MD Atlas
TikkiTeam Oy

EUDAMED last updated this device on Nov 17, 2021

TT-Painopeitto Pro Helmi Baby 2kg

6429810684PROHELMIJK

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TikkiTeam Oy
UDI-DI code: 06429810684004
Reference / catalog number: TT-Painopeitto Pro Helmi Baby 2kg

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: TikkiTeam Oy
SRN: FI-MF-000013094
Manufacturer status: Inactive

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Nov 17, 2021	Jan 1, 2040

Device identification

Trade name: not provided
UDI-DI code: 06429810684004
Basic UDI-DI: 6429810684PROHELMIJK
Reference / catalog number: TT-Painopeitto Pro Helmi Baby 2kg
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: 50
Additional product description: The weighted blanket is a therapeutic device. The blanket is weighted, gives a hugging effect around the body and warming. The weighted blanket is often used as a therapeutic helping device in therapy sessions for e.g. persons with Autism, ADHD, ADD or other neurodevelopment disorder. The weighted blanket can also be used to help in daily chores in hospitals, schools and homes.
Additional information URL: https://www.tikkiteam.com/
Clinical sizes: 2 MU53
80 MU20
70 MU20

EMDN nomenclature code(s)

Z12069099VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS - 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

TT-Painopeitto Pro Pallo 7kg6429810684PROPALLOLQOn the market TT-Painopeitto Pro Pallo Junior 4kg6429810684PROPALLOLQOn 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.