Notified Body
NB 0120
🇬🇧 United Kingdom
SGS United Kingdom Limited
Rossmore Business Park Ellesmere Port Cheshire CH65 3EN, CH65 3EN Port Cheshire, United Kingdom
View on EUDAMED
Updated Oct 1, 2021
Certificates
4
Valid
0
Expiring < 6mo
0
Expired
0
Basic UDI-DIs
27
Devices
27
Manufacturers
2
Cert. Types
2
Basic Information
- Address
- Rossmore Business Park Ellesmere Port Cheshire CH65 3EN, CH65 3EN Port Cheshire, United Kingdom
- Phone
- 44 (0)1934 522917
Regulatory Overview
Regulation
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Eu Ivdd
25
Eu Mdd
2
Classification
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Eu Ivd General
25
Eu Md Class 1
1
Eu Md Class 2a
1
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | PK15/92688.01 | Surgicrafts | Feb 16, 2027 | |||
| IVDD Annex III Section 6 | BE24/00000082 | D-tek s.a. | Jun 18, 2027 | |||
| IVDD Annex III Section 6 | BE24-00000082 | D-tek s.a. | Jun 18, 2027 | |||
| IVDD Annex III Section 6 | BE/2400000082 | D-tek s.a. | Jun 18, 2027 |
Manufacturer Portfolio
| Manufacturer | Certificates | |||
|---|---|---|---|---|
| D-tek s.a. | 🇧🇪 Belgium | 3 | 0 | 0 |
| Surgicrafts | 🇵🇰 Pakistan | 1 | 0 | 0 |