EU Manufacturer
๐บ๐ธ United States
Active
Galvanize Therapeutics, Inc.
SRN: US-MF-000012701
ยท
Bridge Parkway 3200, 94065 Redwood City, United States
Basic UDI-DIs
7
Total Devices
7
On Market
4
Off Market
3
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
11
Basic Information
- Address
- Bridge Parkway 3200, 94065 Redwood City, United States
- [email protected]
- Phone
- +1 650 2684 252
- Website
- https://galvanizetx.com/
Regulatory Overview
Regulation
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Eu Mdr
4
Eu Mdd
3
Classification
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Eu Md Class 1
3
Eu Md Class 2a
2
Eu Md Class 2b
2
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Expired / Withdrawn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) | 35782 | GMED SAS | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 11 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ซ๐ท France
๐ญ๐ท Croatia
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ต๐น Portugal
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CENTAURI Connect | EU MDR | Eu Md Class 1 | On Market | 0 |
| CENTAURI Generator | EU MDR | Eu Md Class 2b | On Market | 0 |
| Compatibility Cable, BW ThermoCool ST | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG Trunk Cable | EU MDR | Eu Md Class 1 | On Market | 0 |
| RheOx Catheter | EU MDD | Eu Md Class 2a | Off Market | 1 |
| RheOx Catheter | EU MDD | Eu Md Class 2a | Off Market | 1 |
| RheOx Generator | EU MDD | Eu Md Class 2b | Off Market | 1 |