EU Manufacturer
๐บ๐ธ United States
Active
Fitbit LLC
SRN: US-MF-000007439
ยท
Fremont St. 215, CA 94105 San Francisco, United States
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
24
Basic Information
- Address
- Fremont St. 215, CA 94105 San Francisco, United States
- [email protected]
- Website
- www.help.fitbit.com
Regulatory Overview
Regulation
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Eu Mdr
4
Eu Mdd
1
Classification
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Eu Md Class 2a
5
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | GCQ 108854 0002 | TรV SรD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 24 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Body Temperature Software | EU MDR | Eu Md Class 2a | On Market | 0 |
| Fitbit ECG App | EU MDD | Eu Md Class 2a | On Market | 1 |
| Fitbit ECG App | EU MDR | Eu Md Class 2a | On Market | 0 |
| Fitbit Irregular Rhythm Notifications | EU MDR | Eu Md Class 2a | On Market | 0 |
| Loss of Pulse Detection | EU MDR | Eu Md Class 2a | On Market | 0 |