EU Manufacturer
🇵🇱 Poland
Active
Przedsiębiorstwo Elektroniki Profesjonalnej IGEL Jerzy Kowaliński
SRN: PL-MF-000022162
·
Chorzowska 64, 44-100 Gliwice, Poland
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Chorzowska 64, 44-100 Gliwice, Poland
- [email protected]
- Phone
- +48 32 271 76 90
- Website
- www.igel.pl
Regulatory Overview
Regulation
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Eu Mdd
2
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Expired / Withdrawn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) | TNP/MDD/0295/4910/2019 | TUV NORD Polska Sp. z o.o | May 25, 2024 |
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 | ||||
|---|---|---|---|---|
| ICARD L Patient Monitor | EU MDD | Eu Md Class 2b | On Market | 1 |
| ICARD M Patient Monitor | EU MDD | Eu Md Class 2b | On Market | 1 |