EU Manufacturer
๐บ๐ธ United States
Active
Pro-Dex, Inc.
SRN: US-MF-000010685
ยท
2361 McGaw Ave, 92614 Irvine, United States
Basic UDI-DIs
22
Total Devices
27
On Market
27
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- 2361 McGaw Ave, 92614 Irvine, United States
- [email protected]
- Phone
- +1 949-769-3200
- Website
- https://www.pro-dex.com/
Regulatory Overview
Regulation
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Eu Mdd
16
Eu Mdr
6
Classification
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Eu Md Class 2a
12
Eu Md Class 1
10
Device Types
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Certificate Health
Total
2
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Expired / Withdrawn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) | 059786 MR2 170726773 | DQS Medizinprodukte GmbH | Mar 29, 2024 | |||
| MDD Annex II (excluding section 4) | 170726773 | DQS Medizinprodukte GmbH | Dec 31, 2028 |
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 | ||||
|---|---|---|---|---|
| MatrixPRO Driver | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO Driver Battery, Sterile | EU MDD | Eu Md Class 1 | On Market | 1 |
| MatrixPRO Driver Battery, Sterile | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO Driver Graphic Case | EU MDD | Eu Md Class 1 | On Market | 0 |
| MatrixPRO Driver Graphic Case | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO Driver Graphic Case Replacement Lid | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO Driver Graphic Case Replacement Lid | EU MDD | Eu Md Class 1 | On Market | 0 |
| MatrixPRO Driver Handpiece | EU MDR | Eu Md Class 2a | On Market | 0 |
| MatrixPRO II 90-Degree Collet, Long | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II 90-Degree Collet, Long | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO II 90-Degree Collet, Short | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II 90-Degree Collet, Short | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO II Driver | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO II Driver | EU MDR | Eu Md Class 2a | On Market | 0 |
| MatrixPRO II Graphic Case | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II Graphic Case | EU MDD | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II Hex Collet | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO II Hex Collet | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II J-Latch Collet | EU MDR | Eu Md Class 1 | On Market | 0 |
| MatrixPRO II J-Latch Collet | EU MDD | Eu Md Class 2a | On Market | 1 |
| MatrixPRO II Single Use Battery | EU MDD | Eu Md Class 1 | On Market | 1 |
| MatrixPRO II Single Use Battery | EU MDR | Eu Md Class 1 | On Market | 0 |
| PRO-DEX Battery Pack | EU MDD | Eu Md Class 1 | On Market | 1 |
| PRO-DEX Surgical Driver | EU MDD | Eu Md Class 2a | On Market | 1 |
| PRO-DEX Surgical Driver | EU MDD | Eu Md Class 2a | On Market | 1 |
| PRO-DEX Surgical Driver | EU MDD | Eu Md Class 2a | On Market | 1 |
| PRO-DEX Surgical Driver | EU MDD | Eu Md Class 2a | On Market | 1 |