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-47136487603C367
- Basic UDI-DI Code
- B-47136487603C367
- Reference
- S70522, S70523
- 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 Set is intended for quantitative measurement of glucose in venous whole blood, neonatal whole blood, or capillary whole blood drawn from the fingers, palm, or forearm. It is intended for in vitro diagnostic use by people with diabetes or by health care professionals, as an aid to monitor glucose level in diabetes mellitus. It is not indicated for diagnosis or screening of diabetes
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0201060102 | BLOOD GLUCOSE METERS |
| W0101060101 | GLUCOSE TEST STRIPS |
| W010106010801 | BLOOD TEST STRIPS CONTROLS |
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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