Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇹🇼 Taiwan
Wellion AMADEUS
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-47136487603C3TY5
- Basic UDI-DI Code
- B-47136487603C3TY5
- Reference
- S5641137, S5641138
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- Apex Biotechnology Corp.
Additional Description
The Wellion AMADEUS Blood Glucose Test Strip is intended to be used with the Wellion AMADEUS Blood Glucose Meter to quantitatively measure glucose in capillary, venous and neonatal whole blood taken from fingers, palm, or forearm. The Wellion AMADEUS Blood Glucose Test Strip is plasma-calibrated for easy comparison to lab results. It is intended for self-testing by people with diabetes and for professional use. It is not to be used for the diagnosis or screening for diabetes.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | HL2100077-1 | TÃœV Rheinland LGA Products GmbH | Expired |
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