EU Manufacturer
๐ฒ๐พ Malaysia
Active
Karex Industries Sdn. Bhd.
SRN: MY-MF-000001247
ยท
PTD 7906 & 7907, Taman Pontian Jaya, , 82000 Pontian, Johor, Malaysia
Basic UDI-DIs
381
Total Devices
418
On Market
418
Off Market
0
Certificates
11
Valid
0
Expiring < 6mo
0
Countries
23
Basic Information
- Address
- PTD 7906 & 7907, Taman Pontian Jaya, , 82000 Pontian, Johor, Malaysia
- [email protected]
- Phone
- +6 03 3165 6688
- Website
- www.karex.com.my
Regulatory Overview
Regulation
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Eu Mdd
380
Eu Mdr
1
Classification
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Eu Md Class 2b
290
Eu Md Class 2a
87
Eu Md Class 3
4
Device Types
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Certificate Health
Total
11
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
11
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G2 102558 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G2 102558 0003 Rev. 01 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 102558 0002 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | No. G2 102558 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 102558 0002 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 102558 0002 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G1 102558 0002 Rev. 01 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex V | G2 102558 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex V | G2 102558 0003G2 102558 0003 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 09556564088226 | TรV SรD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 620880 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 23 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| 4MACIE | EU MDD | Eu Md Class 2b | On Market | 1 |
| 4MACIE | EU MDD | Eu Md Class 2b | On Market | 1 |
| AK Medical | EU MDD | Eu Md Class 2a | On Market | 1 |
| AKSEPT | EU MDD | Eu Md Class 2b | On Market | 1 |
| Amarelle Xtra | EU MDD | Eu Md Class 2b | On Market | 1 |
| Amed | EU MDD | Eu Md Class 2a | On Market | 1 |
| Amed | EU MDD | Eu Md Class 2a | On Market | 1 |
| Amed | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aptor | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aptor | EU MDD | Eu Md Class 2a | On Market | 1 |
| Aptor | EU MDD | Eu Md Class 2a | On Market | 1 |
| BIRR | EU MDD | Eu Md Class 2a | On Market | 1 |
| BIRR | EU MDD | Eu Md Class 2a | On Market | 1 |
| BRED | EU MDD | Eu Md Class 2b | On Market | 1 |
| BRED | EU MDD | Eu Md Class 2b | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| Best Scan | EU MDD | Eu Md Class 2a | On Market | 1 |
| C1530DBEVF (Aloe Vera) | EU MDD | Eu Md Class 2a | On Market | 1 |
| Cahnos | EU MDD | Eu Md Class 2a | On Market | 1 |
| Carex Classic | EU MDD | Eu Md Class 2b | On Market | 1 |
| Carex Classic | EU MDD | Eu Md Class 2b | On Market | 1 |
| Carex Extra Forte | EU MDD | Eu Md Class 2b | On Market | 1 |
| Confortex | EU MDD | Eu Md Class 2a | On Market | 1 |
| Confortex Forte | EU MDD | Eu Md Class 2b | On Market | 1 |
| Confortex Fresa | EU MDD | Eu Md Class 2b | On Market | 1 |
| Confortex Nature | EU MDD | Eu Md Class 2b | On Market | 1 |
| Curamor | EU MDD | Eu Md Class 2a | On Market | 1 |
| Curamor | EU MDD | Eu Md Class 2a | On Market | 1 |
| DUO Gel | EU MDD | Eu Md Class 2a | On Market | 1 |
| DUO Gel | EU MDD | Eu Md Class 2a | On Market | 1 |
| Dildoking Naturelle | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Belgium) Originals XXL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (France) Comfort XXL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (France) Perfect Gliss | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Germany) Perfect Glide | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Italy) 3XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Italy) Comfort XXL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Italy) Settebello 2XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Italy) Settebello 3XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Poland) Perfect Gliss | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Spain) Natural XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Spain) Natural XL | EU MDD | Eu Md Class 2b | On Market | 1 |
| Durex (Spain) Perfect Connection | EU MDD | Eu Md Class 2b | On Market | 1 |