Eu Ivdd
Eu Ivd Self Testing
On The Market
๐จ๐ณ China
HCG - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1
Basic Information
- Primary DI
- 06941571804557
- Basic UDI-DI Code
- B-06941571804557
- Reference
- R04-140
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
Additional Description
The hCG Panel Test is intended for detecting early pregnancy as well as providing a semi quantitative urine hCG level with pregnancy progression. The hCG Panel Test is also intended for semi-quantitatively track urine hCG level after a medical abortion. It is used for self-test.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 107987 0002 | TรV SรD Product Service GmbH | Expired |
Available In Countries
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐น Lithuania
๐ฑ๐ป Latvia
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ท๐ด Romania
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