EU Manufacturer
🇺🇸 United States
Active
Parkell Inc.
SRN: US-MF-000003761
·
Executive Drive 300, 11717 Edgewood, United States
Basic UDI-DIs
79
Total Devices
131
On Market
122
Off Market
9
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Executive Drive 300, 11717 Edgewood, United States
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
55
Eu Mdr
24
Classification
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Eu Md Class 2a
55
Eu Md Class 1
24
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Expired / Withdrawn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) | US19/819943643 | SGS Belgium NV | Jul 04, 2023 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Absolute Dentin® | EU MDD | Eu Md Class 2a | On Market | 1 |
| Absolute Dentin® | EU MDD | Eu Md Class 2a | On Market | 1 |
| Absolute Dentin® | EU MDD | Eu Md Class 2a | On Market | 1 |
| Absolute Dentin® | EU MDD | Eu Md Class 2a | On Market | 1 |
| Absolute Dentin® | EU MDD | Eu Md Class 2a | On Market | 1 |
| Accu-Film® | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm I | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm I | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm II | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm II | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm II | EU MDR | Eu Md Class 1 | On Market | 0 |
| AccuFilm II | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Blu-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Burnett Power-Tip™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Burnett Power-Tip™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Burnett Power-Tip™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Cinch® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Comfort Grip™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Comfort Grip™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Digitest™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DryZ® | EU MDR | Eu Md Class 1 | On Market | 0 |
| DuraTip® | EU MDD | Eu Md Class 2a | On Market | 1 |
| DuraTip® | EU MDD | Eu Md Class 2a | On Market | 1 |
| GentleCLEAN™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| GentleCLEAN™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| GentleCLEAN™ | EU MDD | Eu Md Class 2a | On Market | 1 |
| Green-Mousse® | EU MDR | Eu Md Class 1 | On Market | 0 |
| Hedgehog™ | EU MDR | Eu Md Class 1 | On Market | 0 |
| Hedgehog™ | EU MDR | Eu Md Class 1 | On Market | 0 |
| Hedgehog™ | EU MDR | Eu Md Class 1 | On Market | 0 |
| Hedgehog™ | EU MDR | Eu Md Class 1 | On Market | 0 |