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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

TT-Painopeitto Pro Pallo 7kg — Class I MDR by TikkiTeam Oy

MD Atlas
TikkiTeam Oy

EUDAMED last updated this device on Nov 17, 2021

TT-Painopeitto Pro Pallo 7kg

6429810684PROPALLOLQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: TikkiTeam Oy
UDI-DI code: 06429810684080
Reference / catalog number: TT-Painopeitto Pro Pallo 7kg

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Manufacturer information

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

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: not provided
UDI-DI code: 06429810684080
Basic UDI-DI: 6429810684PROPALLOLQ
Reference / catalog number: TT-Painopeitto Pro Pallo 7kg
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: No clinical sizes registered for this device.

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 Helmi Baby 2kg6429810684PROHELMIJKOn 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.