EU Manufacturer
๐บ๐ธ United States
Active
DeRoyal Industries, Inc.
SRN: US-MF-000002102
ยท
DeBusk Ln 200, 37849 Powell, United States
Basic UDI-DIs
255
Total Devices
428
On Market
428
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- DeBusk Ln 200, 37849 Powell, United States
- [email protected]
- Phone
- +1 865 362 1256
- Website
- www.deroyal.com
Regulatory Overview
Regulation
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Eu Mdd
206
Eu Mdr
49
Classification
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Eu Md Class 1
145
Eu Md Class 2b
71
Eu Md Class 2a
39
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Expired / Withdrawn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) | 10000408810-PA-NA-DNK | DNV Product Assurance AS | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | Directive 93/42/EEC Annex II excluding section 4 | DNV Product Assurance AS | 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 | ||||
|---|---|---|---|---|
| 10' High Flow Insufflation Tubing | EU MDD | Eu Md Class 2a | On Market | 1 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Ankle Contracture Boot | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| Arm Positioner, Surgical | EU MDR | Eu Md Class 1 | On Market | 0 |
| BODY TEMPERATURE MONITORING PROBES - OTHER | EU MDD | Eu Md Class 2b | On Market | 1 |
| Bed Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bed Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bed Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bed Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bed Rail Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bed Rail Pads | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bipolar Cord | EU MDD | Eu Md Class 1 | On Market | 1 |
| Bipolar Cord | EU MDR | Eu Md Class 1 | On Market | 0 |
| Black Foam, NPWT | EU MDD | Eu Md Class 2b | On Market | 1 |
| Black Foam, NPWT | EU MDD | Eu Md Class 2b | On Market | 1 |
| Black Foam, NPWT | EU MDD | Eu Md Class 2b | On Market | 1 |