EU Manufacturer
🇰🇷 South Korea
Active
Mediwhale, Inc
SRN: KR-MF-000011626
·
Nonhyeon-ro, Gangnam-gu 746, 06049 Seoul, South Korea
Basic UDI-DIs
2
Total Devices
2
On Market
1
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Nonhyeon-ro, Gangnam-gu 746, 06049 Seoul, South Korea
- [email protected]
- Website
- https://mediwhale.com/
Regulatory Overview
Regulation
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Eu Mdd
1
Eu Mdr
1
Classification
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Eu Md Class 2a
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | KR21/81826550 | SGS Belgium NV | Dec 31, 2028 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇵🇱 Poland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Dr.Noon | EU MDD | Eu Md Class 2a | On Market | 1 |
| VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE | EU MDR | Eu Md Class 2a | Not EU | 0 |