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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

165_300 — Class I MDR by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Nov 24, 2021

165_300

6418029IPCOLDHOTPACKTC

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06418029906212
Reference / catalog number: 165_300

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Manufacturer information

Organization name: Fysioline Oy
SRN: FI-MF-000001173
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.

Critical warnings

2 warnings recorded — scroll inside the panel to see all entries.

CW135
Keep out of the sight and reach of children.
CW011
For protection against frostbites / burns place a towel or cloth between the pack and the skin. Apply for max 20 min at a time, at 4-6 h intervals. For external use only. Ask your physician about the use of this product if you have diabetes or cardiovascular disease. Keep out of the sight and reach of children. Consult your physician if symptoms persist or worsen.

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: 06418029906212
Basic UDI-DI: 6418029IPCOLDHOTPACKTC
Reference / catalog number: 165_300
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: Reusable Cold / Hot Pack.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 290 MU50
120 MU50

EMDN nomenclature code(s)

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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

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