Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
ACCU-ANSWER
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-697191378-HTSKG
- Basic UDI-DI Code
- B-697191378-HTSKG
- Reference
- HB01
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Guilin Royalyze Medical Instrument Co., Ltd.
Additional Description
Hemoglobin Test Strips are used combination with Multi-Monitoring Meter, intended for quantitatively measuring Hemoglobin level of fresh capillary whole blood derived from the human body solely to provide information for anemia, blood loss auxiliary diagnosis purposes. This system used by lay person.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060199 | BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2156856-1 | TÜV Rheinland LGA Products GmbH | Expired |
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