EU Manufacturer
๐บ๐ธ United States
Active
Spectranetics Corporation
SRN: US-MF-000020669
ยท
Federal Drive 9965, 80921 Colorado Springs, United States
Basic UDI-DIs
198
Total Devices
198
On Market
198
Off Market
0
Certificates
12
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Federal Drive 9965, 80921 Colorado Springs, United States
- [email protected]
- Phone
- n/a
- Website
- n/a
Regulatory Overview
Regulation
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Eu Mdd
198
Classification
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Eu Md Class 3
143
Eu Md Class 2a
51
Eu Md Class 2b
4
Device Types
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Certificate Health
Total
12
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
12
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | CE 661862 | BSI Group The Netherlands B.V. | Nov 20, 2021 | |||
| MDD Annex II Section 4 | CE 579514 | BSI Group The Netherlands B.V. | Feb 28, 2022 | |||
| MDD Annex II (excluding section 4) | CE 579513 | BSI Group The Netherlands B.V. | Feb 28, 2022 | |||
| MDD Annex II Section 4 | CE 634229 | BSI Group The Netherlands B.V. | Dec 30, 2022 | |||
| MDD Annex II Section 4 | CE 611537 | BSI Group The Netherlands B.V. | Mar 24, 2024 | |||
| MDD Annex II Section 4 | CE 611679 | BSI Group The Netherlands B.V. | May 11, 2024 | |||
| MDD Annex II Section 4 | CE 632474 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 550209 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 554849 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 554813 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | CE 632473 | BSI Group The Netherlands B.V. | May 26, 2024 | |||
| MDD Annex II Section 4 | CE 650647 | BSI Group The Netherlands B.V. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom