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Vanadis Core T21/T18/T13 Reagent Cartridge
EUDAMEDClass IVD Annex II List B (EU MDR)
Ref 3222-001BRef 3222-0010
by Wallac Oy
Identity
- Trade Name
- Vanadis Core T21/T18/T13 Reagent Cartridge EUDAMED
- Device Name
- Vanadis Core T21/T18/T13 Reagent Cartridge EUDAMED
- Model / Reference
- 3222-001B EUDAMED3222-0010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438147368716 EUDAMED06438147378500 EUDAMED
- Basic UDI-DI
- B-06438147368716 EUDAMEDB-06438147378500 EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD Annex II List B EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
Vanadis Core T21/T18/T13 Reagent Cartridge by Wallac Oy — Class IVD Annex II List B — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147368716 | Class IVD Annex II List B | Active |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED d376fb31-a690-4c3c-a060-b64eddebf7a5 61 fields · synced Jul 10, 2026
- EUDAMED e548990e-926c-4c35-9245-f88c0e2cb0c1 61 fields · synced May 18, 2026