Eu Mdd
Eu Md Class 2b
On The Market
๐จ๐ด Colombia
UNIQ PULL CONDOM EXS
Devices (same UDI-DI)
1
Certificates
1
Countries
32
Notified Bodies
1
Basic Information
- Primary DI
- 07708612425114
- Basic UDI-DI Code
- B-07708612425114
- Reference
- UNIQ PULL CONDOM EXS
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- UNIQUE INTERNATIONAL SAS
Additional Description
Novelty developed by UNIQUE INTERNATIONAL SAS, for exclusive male use, similar to traditional condoms in its shape, but made from synthetic resin AT-10, it has two side ribbons to facilitate the unrolling of the condom. Complying with the standards for Class IIB medical devices according to MDR 2017/745 and National Decree 4725/2005. And according to MDSAP for medical devices (SOR/98-282) Class III.
CND Nomenclature Codes
| Code | Description |
|---|---|
| U110101 | CONDOMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2906GB454230906 | DNV MEDCERT GmbH |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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