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Organization name
UDI-DI code
Reference / catalog number

Sulfax Cold Spray — Class IIa MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Dec 9, 2021

Sulfax Cold Spray

B-06418029904768

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06418029904768
Reference / catalog number: 800_200

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Manufacturer information

Organization name: Fysioline Oy
SRN: FI-MF-000001173
Manufacturer status: Active

Critical warnings

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

CW054
Extremely flammable aerosol.
CW268
Pressurized container: May burst if heated.
CW139
Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
CW140
Do not spray on an open flame or other ignition source.
CW157
Do not pierce or burn, even after use.
CW135
Keep out of reach of children.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	Nov 3, 2016	Still on market

Device identification

Trade name: Sulfax Cold Spray
UDI-DI code: 06418029904768
Basic UDI-DI: B-06418029904768
Reference / catalog number: 800_200
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Cooling Sulfax Cold spray relieves pain by its cooling properties. Use Sulfax Cold spray with sprains, strains and bruises. Spray several short bursts from minimum distance of 15 cm to avoid local frost bites.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 200 MU03

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

800_546B-84353737087347JOn the market 800_350B-64129889131687JOn the market 704_001B-06418029707000On the market 704_010B-06418029707017On the market 704_0001B-06418029905994On 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.