EU Manufacturer
🇨🇳 China
Active
Shanghai MicroPort EP MedTech Co., Ltd.
SRN: CN-MF-000008518
·
Tianxiong Rd. Building 23&26&28, Lane 588, 201318 Shanghai, China
Basic UDI-DIs
12
Total Devices
37
On Market
37
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
9
Basic Information
- Address
- Tianxiong Rd. Building 23&26&28, Lane 588, 201318 Shanghai, China
- [email protected]
Regulatory Overview
Regulation
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Eu Mdr
8
Eu Mdd
4
Classification
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Eu Md Class 1
8
Eu Md Class 2a
2
Eu Md Class 2b
2
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | G1 081711 0023 | TÜV SÜD Product Service GmbH | Sep 17, 2023 | |||
| MDD Annex II (excluding section 4) | G1 081711 0023 | TÜV SÜD Product Service GmbH | Sep 17, 2023 |
Market Presence
Devices from this manufacturer are available in 9 countries across Europe.
🇧🇬 Bulgaria
🇩🇪 Germany
🇬🇷 Greece
🇪🇸 Spain
🇫🇷 France
🇮🇹 Italy
🇳🇱 Netherlands
🇵🇹 Portugal
🇹🇷 Türkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Columbus™ Cardiac Electrophysiology Stimulator | EU MDD | Eu Md Class 2b | On Market | 1 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ External Reference Patch | EU MDR | Eu Md Class 1 | On Market | 0 |
| Columbus™ Reference Patch | EU MDD | Eu Md Class 2a | On Market | 1 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for 3D Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for CryoAblation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Mapping Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Mapping Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Mapping Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for Mapping Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for TrueForce™ Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for TrueForce™ Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Cable for TrueForce™ Ablation Catheter | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Coaxial Umbilical | EU MDR | Eu Md Class 1 | On Market | 0 |
| FORLNK™ Manual Retraction Kit | EU MDR | Eu Md Class 1 | On Market | 0 |
| OptimAblate™ Cardiac RF Generator | EU MDD | Eu Md Class 2b | On Market | 1 |
| OptimAblate™ Irrigation Pump | EU MDD | Eu Md Class 2a | On Market | 1 |