EU Manufacturer
๐บ๐ธ United States
Active
GE Medical Systems, LLC
SRN: US-MF-000018315
ยท
N Grandview Blvd 3000, 53188 Waukesha, United States
Basic UDI-DIs
12
Total Devices
18
On Market
18
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Watch GE Medical Systems, LLC for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- N Grandview Blvd 3000, 53188 Waukesha, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdr
10
Eu Mdd
2
Classification
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Eu Md Class 2b
6
Eu Md Class 2a
5
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Expired / Withdrawn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) | 15101 | GMED SAS | May 26, 2024 |
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 | ||||
|---|---|---|---|---|
| AMX Navigate | EU MDR | Eu Md Class 2b | On Market | 0 |
| AMX Navigate UPGRADE | EU MDR | Eu Md Class 2b | On Market | 0 |
| Auto Segmentation | EU MDR | Eu Md Class 2b | On Market | 0 |
| Discovery IQ | EU MDR | Eu Md Class 2b | On Market | 0 |
| Discovery MI Gen2 | EU MDR | Eu Md Class 2b | On Market | 0 |
| Head Auto Views | EU MDR | Eu Md Class 2a | On Market | 0 |
| Quality Care Suite 2.0 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Revolution Apex Elite | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution Apex Plus | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution CT | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution CT ES | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution CT ES with Apex edition | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution CT with Apex edition | EU MDR | Eu Md Class 2b | On Market | 0 |
| Revolution UPG 3 | EU MDR | Eu Md Class 2b | On Market | 0 |
| SnapShot Freeze 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| SnapShot Freeze 2 | EU MDD | Eu Md Class 2a | On Market | 1 |
| Spectral Bone Marrow | EU MDR | Eu Md Class 2a | On Market | 0 |
| Spectral Color Overlay | EU MDR | Eu Md Class 2a | On Market | 0 |