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Vanadis Core Reagent Cartridge II
EUDAMEDClass C (EU MDR)
Ref 3222-002B
by Wallac Oy
Identity
- Trade Name
- Vanadis Core Reagent Cartridge II EUDAMED
- Device Name
- Vanadis Core Reagent Cartridge II EUDAMED
- Model / Reference
- 3222-002B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147382507 EUDAMED
- Basic UDI-DI
- 6438147Vanadis_RC2XU EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
Yes
EUDAMED
Vanadis Core Reagent Cartridge II by Wallac Oy — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147Vanadis_RC2XU | Class C | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (1)
- EUDAMED 1eeef552-44c4-469f-90d8-774092c5804e 61 fields · synced Jul 17, 2026