Eu Ivdd
Eu Ivd Annex 2 List B
On The Market
🇯🇵 Japan
GLUCOCARD S onyx (GT-7120)
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
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Basic Information
- Primary DI
- D-108481NA
- Basic UDI-DI Code
- B-108481NA
- Reference
- 108481
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Annex 2 List B
- Status
- On The Market
- Manufacturer
- ARKRAY Factory, Inc.
Additional Description
Test meter (01-10241) / Lancing Device (01-09603) / Lancet (01-09591) / Test Strips (108496)
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101060101 | GLUCOSE TEST STRIPS |
| W0201060102 | BLOOD GLUCOSE METERS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 027591 0045 | TÜV SÜD Product Service GmbH | Expired |
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