EU Manufacturer
๐น๐ญ Thailand
Active
Eclipse Medical Co. Ltd
SRN: TH-MF-000021672
ยท
88/62 Moo 1, 345 Road, 11120 Nonthaburi, Thailand
Basic UDI-DIs
23
Total Devices
23
On Market
23
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
11
Basic Information
- Address
- 88/62 Moo 1, 345 Road, 11120 Nonthaburi, Thailand
- [email protected]
- Website
- www.eclipsemedical.biz
Regulatory Overview
Regulation
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Eu Mdd
23
Classification
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Eu Md Class 2b
13
Eu Md Class 3
10
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-177/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II Section 4 | 1434-MDD-176/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II (excluding section 4) | 1434-MDD-179/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| MDD Annex II Section 4 | 1434-MDD-178/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 11 countries across Europe.
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฒ๐น Malta
๐ณ๐ด Norway
๐ต๐น Portugal
๐ธ๐ช Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ChekFLO Vascular Plug II โ 10 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 12 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 14 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 16 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 18 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 20 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 22 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 4 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 6 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug II โ 8 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug IV โ 4 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug IV โ 6 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| ChekFLO Vascular Plug IV โ 8 mm | EU MDD | Eu Md Class 2b | On Market | 2 |
| OMEGA LAA Occluder 14mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 16mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 18mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 20mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 22mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 24mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 26mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 28mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder 30mm | EU MDD | Eu Md Class 3 | On Market | 2 |
| OMEGA LAA Occluder Delivery System 14F | EU MDD | Eu Md Class 3 | On Market | 2 |