EU Manufacturer
๐บ๐ธ United States
Active
Abiomed Inc.
SRN: US-MF-000016855
ยท
Cherry Hill Drive 22, 01923 Danvers, United States
Basic UDI-DIs
11
Total Devices
13
On Market
13
Off Market
0
Certificates
5
Valid
0
Expiring < 6mo
0
Countries
21
Basic Information
- Address
- Cherry Hill Drive 22, 01923 Danvers, United States
- [email protected]
- Phone
- +1 978 646-1400
- Website
- abiomed.com
Regulatory Overview
Regulation
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Eu Mdd
10
Eu Mdr
1
Classification
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Eu Md Class 2a
5
Eu Md Class 3
3
Eu Md Class 1
2
Eu Md Class 2b
1
Device Types
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Certificate Health
Total
5
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
5
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 11931GB411191211A | DNV MEDCERT GmbH | Dec 31, 2022 | |||
| MDD Annex II Section 4 | 11935GB411190920 | DNV MEDCERT GmbH | Mar 26, 2023 | |||
| MDD Annex V | 2817GB415210518A | DNV MEDCERT GmbH | Nov 28, 2023 | |||
| MDD Annex II (excluding section 4) | 2817GB410190207 | DNV MEDCERT GmbH | Nov 28, 2023 | |||
| MDD Annex II Section 4 | 11934GB411190716 | DNV MEDCERT GmbH | Apr 02, 2024 |
Market Presence
Devices from this manufacturer are available in 21 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ฌ๐ง United Kingdom