EU Manufacturer
๐บ๐ธ United States
Active
X-Nav Technologies, LLC
SRN: US-MF-000003234
ยท
Bustard Rd 1555, 19446 Lansdale, United States
Basic UDI-DIs
20
Total Devices
34
On Market
34
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
29
Basic Information
- Address
- Bustard Rd 1555, 19446 Lansdale, United States
- [email protected]
- Website
- x-navtech.com
Regulatory Overview
Regulation
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Eu Mdd
16
Eu Mdr
4
Classification
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Eu Md Class 2a
18
Eu Md Class 1
2
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 41371240 | INTERTEK SEMKO AB | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 41371240-03 | INTERTEK SEMKO AB | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 29 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
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| EDX Bone Screw and Cap | EU MDR | Eu Md Class 2a | On Market | 0 |
| FastMap | EU MDR | Eu Md Class 1 | On Market | 0 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDR | Eu Md Class 1 | On Market | 0 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES | EU MDD | Eu Md Class 2a | On Market | 1 |
| X-Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| X-Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| X-Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| X-Guide | EU MDD | Eu Md Class 2a | On Market | 1 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide Bone Screws | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide System | EU MDR | Eu Md Class 2a | On Market | 0 |
| X-Guide System | EU MDR | Eu Md Class 2a | On Market | 0 |