EU Manufacturer
🇰🇷 South Korea
Active
SPECLIPSE, Inc.
SRN: KR-MF-000040868
·
Sandan-ro 232, 15433 Danwon-gu, Ansan-si, Gyeonggi-do, South Korea
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Sandan-ro 232, 15433 Danwon-gu, Ansan-si, Gyeonggi-do, South Korea
- [email protected]
- Phone
- +82-31-483-8400
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 2b
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | CE-MDD-0133/04/2021/01 | Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇨🇾 Cyprus
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| NEODYMIUM SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |
| NEODYMIUM SURGICAL LASER | EU MDD | Eu Md Class 2b | On Market | 1 |