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

Sulfax Optima Formula — Class I MDD by Fysioline Oy

MD Atlas
Fysioline Oy

EUDAMED last updated this device on Jan 3, 2022

Sulfax Optima Formula

B-06224008073451

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Fysioline Oy
UDI-DI code: 06224008073451
Reference / catalog number: 800_570

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

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW011
Avoid contact with eyes, mucous membranes and wounds. Product may cause an allergic reaction if person is allergic to crustaceans. Keep out of reach of children. For external use only.

Market distribution

Primary placement in Finland; available across 1 country total.

Country	On market since	Until
FinlandPrimary placement	May 7, 2018	Still on market

Device identification

Trade name: Sulfax Optima Formula
UDI-DI code: 06224008073451
Basic UDI-DI: B-06224008073451
Reference / catalog number: 800_570
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Sulfax Optima Formula cooling cream effectively and rapidly relieves pain and reduces inflammation on joint areas.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU24

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.