EU Manufacturer
🇵🇱 Poland
Active
HTL-Strefa S.A.
SRN: PL-MF-000002198
·
Adamówek 7, 95-035 Ozorków, Poland
Basic UDI-DIs
10
Total Devices
70
On Market
70
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
18
Basic Information
- Address
- Adamówek 7, 95-035 Ozorków, Poland
- [email protected]
- Phone
- +48 664140189
- Website
- www.htl-strefa.com
Regulatory Overview
Regulation
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Eu Mdd
7
Eu Mdr
3
Classification
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Eu Md Class 2a
10
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 84587CE01 | TÜV Rheinland LGA Products GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇮🇹 Italy
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ACCU-FINE | EU MDD | Eu Md Class 2a | On Market | 1 |
| ACCU-FINE | EU MDD | Eu Md Class 2a | On Market | 1 |
| Accu-Fine | EU MDD | Eu Md Class 2a | On Market | 1 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| Accu-Fine | EU MDR | Eu Md Class 2a | On Market | 0 |
| AviFine | EU MDR | Eu Md Class 2a | On Market | 0 |
| AviFine | EU MDR | Eu Md Class 2a | On Market | 0 |
| AviFine | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDR | Eu Md Class 2a | On Market | 0 |
| DropSafe | EU MDD | Eu Md Class 2a | On Market | 1 |
| DropSafe | EU MDD | Eu Md Class 2a | On Market | 1 |
| DropSafe | EU MDD | Eu Md Class 2a | On Market | 1 |
| MedicoFINE | EU MDR | Eu Md Class 2a | On Market | 0 |
| MedicoFINE | EU MDR | Eu Md Class 2a | On Market | 0 |
| Microdot droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| Microdot droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| Microdot droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| Securlancets Unik | EU MDD | Eu Md Class 2a | On Market | 1 |
| Sicherheits-Pen-Nadeln | EU MDR | Eu Md Class 2a | On Market | 0 |
| Sicherheits-Pen-Nadeln | EU MDR | Eu Md Class 2a | On Market | 0 |
| diamet mySafety | EU MDR | Eu Md Class 2a | On Market | 0 |
| diamet mySafety | EU MDR | Eu Md Class 2a | On Market | 0 |
| diamet mySafety | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |
| droplet | EU MDR | Eu Md Class 2a | On Market | 0 |