Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
One-Step Pregnancy Test
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-6909620WHSHCG8DGP
- Basic UDI-DI Code
- B-6909620WHSHCG8DGP
- Reference
- WH-FT-S0x0101; WH-FT-S0x0102; WH-FT-S0x0103; WH-FT-S0x0107
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- W.H.P.M. Bioresearch & Technology Co., Ltd.
Additional Description
The One Step Pregnancy Test is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. Currently our products are in the format of strip, cassette, discard and midstream. All formats are packed and sealed in aluminum foil bags to ensure its validity before its expiration.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102160302 | HCG - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL 2101523-1 | TÃœV Rheinland LGA Products GmbH | Expired |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Self Testing) and regulation (EU IVDD).
CERA-CHEKâ„¢ Lactate Measuring System
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
CERA-CHEKâ„¢ Lactate Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·GC MEDIS Corp.·On the market·2 countries
BGI
Device
EU IVDD
·
Eu Ivd Self Testing
·BGI EUROPE A/S·On the market
Lactate Pro 2 (LT-1730)
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market
Lactate Pro 2 Test Strip
Device
EU IVDD
·
Eu Ivd Self Testing
·ARKRAY Factory, Inc.·On the market