OneMed Group Oy

SRN: FI-MF-000000642 · Metsäläntie 20, 00320 Helsinki, Finland

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Basic UDI-DIs

Total Devices

892

On Market

750

Off Market

142

Certificates

Valid

Expiring < 6mo

Countries

Watch OneMed Group Oy for changes

We'll email you when it registers new devices, or a certificate is issued or withdrawn.

Basic Information

Address: Metsäläntie 20, 00320 Helsinki, Finland
Email: [email protected]

Regulatory Overview

Regulation

Eu Mdr 50

Eu Mdd 1

Classification

Eu Md Class 1 38

Eu Md Class 2a 13

Device Types

Certificate Health

No certificates registered for this manufacturer.

Market Presence

Devices from this manufacturer are available in 18 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇨🇿 Czechia 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇪🇸 Spain 🇫🇮 Finland 🇮🇹 Italy 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇵🇹 Portugal 🇸🇪 Sweden 🇸🇰 Slovakia

Device Portfolio

Name	Regulation	Classification	Market Status
Apoteket Hjärtat ICA® Undersökningshandske, vinyl, för ömtåliga händer, puder och ftalatfria, 10 st, size L	EU MDR	Eu Md Class 1	On Market
Apoteket Hjärtat ICA® Undersökningshandske, vinyl, för ömtåliga händer, puder och ftalatfria, 10 st, size M	EU MDR	Eu Md Class 1	On Market
Apoteket Hjärtat ICA® Undersökningshandske, vinyl, för ömtåliga händer, puder och ftalatfria, 100 st, size L	EU MDR	Eu Md Class 1	On Market
Apoteket Hjärtat ICA® Undersökningshandske, vinyl, för ömtåliga händer, puder och ftalatfria, 100 st, size M	EU MDR	Eu Md Class 1	On Market
Apoteket Hjärtat ICA® Undersökningshandske, vinyl, för ömtåliga händer, puder och ftalatfria, 100 st, size S	EU MDR	Eu Md Class 1	On Market
Apoteket Nonwoven swabs 5 x 5 cm, 4-ply, 100 pcs, non-sterile	EU MDR	Eu Md Class 1	On Market
Apoteket® Vinylhandskar, puder och ftalatfria, 10 st, size M	EU MDR	Eu Md Class 1	On Market
Apoteket® Vinylhandskar, puder och ftalatfria, 100 st, size L	EU MDR	Eu Md Class 1	On Market
Apoteket® Vinylhandskar, puder och ftalatfria, 100 st, size M	EU MDR	Eu Md Class 1	On Market
Apoteket® Vinylhandskar, puder och ftalatfria, 100 st, size S	EU MDR	Eu Md Class 1	On Market
Embra® Latex Medical Exam Gloves, powder-free, FLEX size L	EU MDR	Eu Md Class 1	On Market
Embra® Latex Medical Exam Gloves, powder-free, FLEX size M	EU MDR	Eu Md Class 1	On Market
Embra® Latex Medical Exam Gloves, powder-free, FLEX size S	EU MDR	Eu Md Class 1	On Market
Embra® Latex Medical Exam Gloves, powder-free, FLEX size XL	EU MDR	Eu Md Class 1	On Market
Embra® Latex Medical Exam Gloves, powder-free, FLEX size XS	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size L	EU MDR	Eu Md Class 1	Off Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size L	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size M	EU MDR	Eu Md Class 1	Off Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size M	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size S	EU MDR	Eu Md Class 1	Off Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size S	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size XL	EU MDR	Eu Md Class 1	Off Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size XL	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size XS	EU MDR	Eu Md Class 1	Off Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED X-LONG, size XS	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED, size L	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED, size M	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED, size S	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED, size XL	EU MDR	Eu Md Class 1	On Market
Embra® Nitrile Medical Exam Gloves, Accelerator-free, green, AQL 1.0, PROCEED, size XS	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven round sponges, diam. 30 mm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven round sponges, diam. 40 mm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven round sponges, diam. 50 mm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 10 cm, 2-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 10 cm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 10 cm, non-sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 20 cm, 2-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 20 cm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 10 x 20 cm, non-sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 5 x 5 cm, 2-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 5 x 5 cm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 5 x 5 cm, non-sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 7,5 x 7,5 cm, 2-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 7,5 x 7,5 cm, 5-pack, sterile	EU MDR	Eu Md Class 1	On Market
Embra® Nonwoven swabs 7,5 x 7,5 cm, non-sterile	EU MDR	Eu Md Class 1	On Market
Embra® Optimia Nonwoven round sponges, diam. 30 mm	EU MDR	Eu Md Class 1	On Market
Embra® Optimia Nonwoven round sponges, diam. 40 mm	EU MDR	Eu Md Class 1	On Market
Embra® Optimia Nonwoven round sponges, diam. 50 mm	EU MDR	Eu Md Class 1	On Market
Embra® Optimia Nonwoven swabs 10 x 10 cm	EU MDR	Eu Md Class 1	On Market
Embra® Optimia Nonwoven swabs 10 x 20 cm	EU MDR	Eu Md Class 1	On Market

View all 892 devices →

PRRC #1

Name

Hilleriikka Vaho

Country

🇫🇮 Finland

PRRC #2

Name

Martin Hillbratt

Country

🇸🇪 Sweden

Competent Authority

Name

Finnish Medicines Agency, Supervision and licences, Medical Device Unit

Country

🇫🇮 Finland

More about this competent authority →

PSUR Report

Search FDA adverse events and recalls name-matched to OneMed Group Oy — useful for PSUR and supplier checks.

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Quick Links

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