EU Manufacturer
๐ธ๐ช Sweden
Active
Oticon Medical AB
SRN: SE-MF-000000724
ยท
Datavรคgen 37B, SE-436 32 Askim, Sweden
Basic UDI-DIs
17
Total Devices
126
On Market
126
Off Market
0
Certificates
0
Valid
0
Expiring < 6mo
0
Countries
19
Basic Information
- Address
- Datavรคgen 37B, SE-436 32 Askim, Sweden
- [email protected]
- Website
- www.oticonmedical.com
Regulatory Overview
Regulation
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Eu Mdr
17
Classification
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Eu Md Class 1
9
Eu Md Class 2a
8
Device Types
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Certificate Health
No certificates registered for this manufacturer.
Market Presence
Devices from this manufacturer are available in 19 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Abutment inserter, machine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Counter torque wrench | EU MDR | Eu Md Class 1 | On Market | 0 |
| Double-ended dissector | EU MDR | Eu Md Class 1 | On Market | 0 |
| FLEX LINK GENIE MEDICAL BAHS 24.2 | EU MDR | Eu Md Class 2a | On Market | 0 |
| GENIE MEDICAL BAHS, SALES PACK 2022.1 DVD UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| GENIE MEDICAL BAHS, SALES PACK 2022.1 USB UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| Genie Medical BAHS, Sales Pack 2021.2 DVD UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| Genie Medical BAHS, Sales Pack 2021.2 USB UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| Guide drill, 3-4mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| Handle with screwdriver | EU MDR | Eu Md Class 2a | On Market | 0 |
| Head band | EU MDR | Eu Md Class 1 | On Market | 0 |
| Healing cap | EU MDR | Eu Md Class 1 | On Market | 0 |
| ISO FILE, GENIE MEDICAL BAHS 2023.1 UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| ISO FILE, GENIE MEDICAL BAHS 2024.2 UK | EU MDR | Eu Md Class 2a | On Market | 0 |
| MIPS Back-up kit, 3mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| MIPS Surgery kit, 4mm | EU MDR | Eu Md Class 2a | On Market | 0 |
| MONO Surgery Kit | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, CBE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, CNB | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, DBL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, Demo, TC | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, SIL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, STG | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 4, TC | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini DEMO, Diamond Black | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, CBE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, CNB | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, DBL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, SIL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, STG | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 Mini, TC | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower DEMO, Diamond Black | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, CBE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, TC | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, CNB | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, DBL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, SIL | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto 5 SuperPower, STG | EU MDR | Eu Md Class 2a | On Market | 0 |
| Ponto Soft band, beige | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, beige | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, black | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, blue | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, brown | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, cerise | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, green | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, grey | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, indigo | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, navy | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, pink | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ponto Soft band, bilateral, purple | EU MDR | Eu Md Class 1 | On Market | 0 |