EU Manufacturer
๐ฎ๐น Italy
Active
Medicap S.r.l
SRN: IT-MF-000007995
ยท
Via A. Lincoln 15, 41012 Carpi, Italy
Basic UDI-DIs
4
Total Devices
5
On Market
5
Off Market
0
Certificates
4
Valid
2
Expiring < 6mo
0
Countries
8
Basic Information
- Address
- Via A. Lincoln 15, 41012 Carpi, Italy
- [email protected]
- Website
- www.biofibre.com
Regulatory Overview
Regulation
Loading...
Eu Mdr
3
Eu Mdd
1
Classification
Loading...
Eu Md Class 2a
2
Eu Md Class 2b
2
Device Types
Loading...
Certificate Health
Total
4
Valid
2
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 004917 | ISTITUTO SUPERIORE DI SANITA' | Jul 12, 2022 | |||
| MDR QMS | CSQ0002220223 | ISTITUTO SUPERIORE DI SANITA' | MDR | Feb 2023 | Dec 22, 2027 | Supplemented |
| MDR Technical Documentation | CVD000122 | ISTITUTO SUPERIORE DI SANITA' | MDR | Dec 2022 | Dec 22, 2027 | Issued |
| MDR Technical Documentation | cvd0001-22 | ISTITUTO SUPERIORE DI SANITA' | โ |
Market Presence
Devices from this manufacturer are available in 8 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| IMPLANTABLE PROSTHETIC DEVICES - OTHER | EU MDD | Eu Md Class 2b | On Market | 1 |
| IMPLANTABLE PROSTHETIC DEVICES - OTHER | EU MDR | Eu Md Class 2b | On Market | 1 |
| IMPLANTABLE PROSTHETIC DEVICES - OTHER | EU MDR | Eu Md Class 2b | On Market | 1 |
| MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER | EU MDR | Eu Md Class 2a | On Market | 0 |
| MINIMALLY INVASIVE SURGERY SURGICAL INSTRUMENT KITS, SINGLE-USE - OTHER | EU MDR | Eu Md Class 2a | On Market | 0 |