EU Manufacturer
๐บ๐ธ United States
Active
Intelligent Hearing Systems Corp.
SRN: US-MF-000011473
ยท
6860 SW 81st Street, 33143 Miami, United States
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
14
Basic Information
- Address
- 6860 SW 81st Street, 33143 Miami, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdr
2
Eu Mdd
1
Classification
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Eu Md Class 2a
2
Eu Md Class 1
1
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Expired / Withdrawn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 (excluding section 4) | 260739-2018-CE-NOR-NA-PS | DNV Product Assurance AS | May 04, 2023 |
Market Presence
Devices from this manufacturer are available in 14 countries across Europe.
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฑ๐ฎ Liechtenstein
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Lilly TM-Wick Electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| MADSEN Capella2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| USB Jr Duet | EU MDR | Eu Md Class 2a | On Market | 0 |