Notified Body
NB 2862
🇸🇪 Sweden
Intertek Medical Notified Body AB
Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
View on EUDAMED
Updated Nov 1, 2022
Certificates
12
Valid
10
Expiring < 6mo
1
Expired
0
Basic UDI-DIs
2
Devices
3
Manufacturers
9
Cert. Types
2
Basic Information
- Address
- Torshamnsgatan 43, Box 1103, SE-164 22 Kista, Sweden
- [email protected]
- Phone
- +46 8 750 00 00
- Website
- www.intertek.se
Regulatory Overview
Regulation
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Eu Mdr
2
Classification
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Eu Md Class 2b
1
Eu Md Class 3
1
Device Types
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Certificate Health
Total
12
Valid
10
Expiring < 6mo
1
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDR QMS | 28620117074 | Agfa HealthCare NV | MDR | Aug 2021 | Aug 24, 2026 | Issued |
| MDR QMS | 28620136171 | Eyenuk, Inc. | MDR | Nov 2022 | Feb 03, 2027 | Issued |
| MDR QMS | 28620136087 | Koios Medical Inc. | MDR | Jun 2023 | Aug 09, 2027 | Issued |
| MDR QMS | 28620156612 | Shenzhen Kentro Medical Electronics CO.,LTD. | MDR | Sep 2023 | Nov 20, 2027 | Issued |
| MDR QMS | 28620140724 | Sri Anusham Rubber Industries Private Limited | MDR | Jan 2023 | Jan 30, 2028 | Issued |
| MDR Technical Documentation | 68620146168 | Innoventa Medica ApS | MDR | Mar 2023 | Mar 20, 2028 | Issued |
| MDR QMS | 28620145188 | Innoventa Medica ApS | MDR | Mar 2023 | Mar 20, 2028 | Issued |
| MDR QMS | 28620156455 | SmileSonica Inc. | MDR | Sep 2023 | Aug 19, 2028 | Issued |
| MDR Technical Documentation | 28620163227 | Front Line Medical Technologies Inc. | MDR | Dec 2023 | Sep 18, 2028 | Issued |
| MDR QMS | 28620177096 | Amalgam Rx, Inc | MDR | Jun 2024 | Oct 02, 2028 | Issued |
| MDR Technical Documentation | 28620163227 | Front Line Medical Technologies Inc. | — | |||
| MDR Technical Documentation | 28620146168 | Innoventa Medica ApS | — |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| Innoventa Medica ApS | 🇩🇰 Denmark | 3 | 2 | 0 |
| Front Line Medical Technologies Inc. | 🇨🇦 Canada | 2 | 1 | 0 |
| Amalgam Rx, Inc | 🇺🇸 United States | 1 | 1 | 0 |
| Eyenuk, Inc. | 🇺🇸 United States | 1 | 1 | 0 |
| SmileSonica Inc. | 🇨🇦 Canada | 1 | 1 | 0 |
| Sri Anusham Rubber Industries Private Limited | 🇮🇳 India | 1 | 1 | 0 |
| Shenzhen Kentro Medical Electronics CO.,LTD. | 🇨🇳 China | 1 | 1 | 0 |
| Koios Medical Inc. | 🇺🇸 United States | 1 | 1 | 0 |
| Agfa HealthCare NV | 🇧🇪 Belgium | 1 | 1 | 1 |