EU Manufacturer
🇩🇪 Germany
Active
metek Medizin Technik Komponenten GmbH
SRN: DE-MF-000006817
·
Bundesstraße 107, 52159 Roetgen, Germany
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Bundesstraße 107, 52159 Roetgen, Germany
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
1
Eu Mdr
1
Classification
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Eu Md Class 2b
2
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Expired / Withdrawn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) | D1436400002 | MDC MEDICAL DEVICE CERTIFICATION GMBH | Jun 27, 2023 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇦🇹 Austria
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES | EU MDD | Eu Md Class 2b | On Market | 1 |
| POLYGRAPHY SYSTEMS FOR HAEMODYNAMIC STUDIES | EU MDR | Eu Md Class 2b | On Market | 0 |