EU Manufacturer
๐จ๐ณ China
Active
Andon Health Co., Ltd.
SRN: CN-MF-000001799
ยท
No 3 Jinping Street YaAn Road, Nankai District, 300190 Tianjin, China
Basic UDI-DIs
8
Total Devices
11
On Market
11
Off Market
0
Certificates
3
Valid
1
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- No 3 Jinping Street YaAn Road, Nankai District, 300190 Tianjin, China
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
5
Eu Mdr
3
Classification
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Eu Md Class 2a
8
Device Types
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Certificate Health
Total
3
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | HD 60149938 0001 | TรV Rheinland LGA Products GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | HD601499380001 | TรV Rheinland LGA Products GmbH | May 26, 2024 | |||
| MDR QMS | HZ 2095583-1 | TรV Rheinland LGA Products GmbH | MDR | Oct 2024 | Oct 09, 2029 | Issued |
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
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Arm Blood Pressure Monitor | EU MDD | Eu Md Class 2a | On Market | 1 |
| Infrared Forehead Thermometer | EU MDD | Eu Md Class 2a | On Market | 1 |
| KD-5920V | EU MDR | Eu Md Class 2a | On Market | 0 |
| NONโINVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS | EU MDR | Eu Md Class 2a | On Market | 0 |
| NONโINVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS | EU MDR | Eu Md Class 2a | On Market | 0 |
| NONโINVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS | EU MDR | Eu Md Class 2a | On Market | 0 |
| TENS | EU MDD | Eu Md Class 2a | On Market | 1 |
| TENS | EU MDD | Eu Md Class 2a | On Market | 1 |
| Wrist Blood Pressure Monitor | EU MDD | Eu Md Class 2a | On Market | 1 |
| Wrist Blood Pressure Monitor | EU MDR | Eu Md Class 2a | On Market | 0 |
| mHealth | EU MDR | Eu Md Class 2a | On Market | 0 |