EU Manufacturer
๐ฎ๐ณ India
Active
Chetan Meditech Pvt. Ltd.
SRN: IN-MF-000013541
ยท
Sanand II GIDC MD-04, 382110 Ahmedabad, Gujarat, India
Basic UDI-DIs
11
Total Devices
11
On Market
11
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- Sanand II GIDC MD-04, 382110 Ahmedabad, Gujarat, India
- [email protected]
- Phone
- +91 9316723174
- Website
- https://www.biotekortho.com/
Regulatory Overview
Regulation
Loading...
Eu Mdr
7
Eu Mdd
4
Classification
Loading...
Eu Md Class 2b
6
Eu Md Class 1
2
Eu Md Class 3
2
Eu Md Class 2a
1
Device Types
Loading...
Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-MDD/QS-021 | 3EC International a.s. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2019-MDD/QS-067/A | 3EC International a.s. | May 26, 2024 | |||
| MDR Technical Documentation | 2024-MDR/TD-031 | 3EC International a.s. | โ |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
๐ฆ๐น Austria
๐ฉ๐ช Germany
๐ซ๐ท France
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ARTHROVIMS ANCHOR LRP | EU MDD | Eu Md Class 2b | On Market | 1 |
| ArthroVIMS ANCHOR LRP | EU MDD | Eu Md Class 2b | On Market | 1 |
| ArthroVims BR | EU MDD | Eu Md Class 3 | On Market | 1 |
| BIO-VIM | EU MDR | Eu Md Class 3 | On Market | 1 |
| BIOTEK | EU MDR | Eu Md Class 2a | On Market | 0 |
| BIOTEK, Fiberknot, ArthroVims Soft Anchor, ArthroVims | EU MDD | Eu Md Class 2b | On Market | 1 |
| BioFiber | EU MDR | Eu Md Class 2b | On Market | 0 |
| BioFix-NP | EU MDR | Eu Md Class 2b | On Market | 0 |
| ONLoc | EU MDR | Eu Md Class 1 | On Market | 0 |
| SOFTFIX-PK | EU MDR | Eu Md Class 2b | On Market | 0 |
| SURESHOT | EU MDR | Eu Md Class 1 | On Market | 0 |