EU Manufacturer
๐ต๐ฑ Poland
Active
HTL-Strefa S.A.
SRN: PL-MF-000002198
ยท
Adamรณwek 7, 95-035 Ozorkรณw, Poland
Basic UDI-DIs
10
Total Devices
70
On Market
70
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
18
Watch HTL-Strefa S.A. for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Adamรณwek 7, 95-035 Ozorkรณw, 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Expired / Withdrawn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 | TรV Rheinland LGA Products GmbH | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 18 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ 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 |