EU Manufacturer
๐บ๐ธ United States
Active
Bimini Health Tech
SRN: US-MF-000008649
ยท
Stevens Avenue 420, 92075 Solana Beach, United States
Basic UDI-DIs
10
Total Devices
10
On Market
10
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Stevens Avenue 420, 92075 Solana Beach, United States
- [email protected]
- Phone
- +1 858 348 8050
- Website
- https://biminihealthtech.com/
Regulatory Overview
Regulation
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Eu Mdd
5
Eu Mdr
5
Classification
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Eu Md Class 2a
7
Eu Md Class 1
3
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Expired / Withdrawn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) | US19/819943606 | SGS Belgium NV | Aug 17, 2023 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Dermapose | EU MDR | Eu Md Class 2a | On Market | 0 |
| GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE | EU MDR | Eu Md Class 1 | On Market | 0 |
| Healeon Duet | EU MDD | Eu Md Class 2a | On Market | 1 |
| INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE | EU MDR | Eu Md Class 1 | On Market | 0 |
| LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER | EU MDR | Eu Md Class 1 | On Market | 0 |
| Puregraft 250 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Puregraft 50 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Puregraft 50 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Puregraft 50 Single Pack | EU MDD | Eu Md Class 2a | On Market | 1 |
| Puregraft 850 | EU MDD | Eu Md Class 2a | On Market | 1 |