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G7 Variant Elution Buffer HSi No.2 (S)
EUDAMEDClass IVD General (EU MDR)
Ref 0019553Ref 0019545
Identity
- Device Name
- G7 Variant Elution Buffer HSi No.2 (S) EUDAMEDG7 HSi Elution Buffer No.2 (S) EUDAMED
- Model / Reference
- 0019553 EUDAMED0019545 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14560189283463 EUDAMED14560189283425 EUDAMED
- Basic UDI-DI
- B-14560189283463 EUDAMEDB-14560189283425 EUDAMED
- EMDN Code
- W01019001 BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC) EUDAMEDW0201060101 GLYCOSILATED HEMOGLOBIN DEVICES EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Belgium 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
G7 Variant Elution Buffer HSi No.2 (S) by Tosoh Corporation — Class IVD General — 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-14560189283463 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Tosoh Corporation
- EUDAMED SRN
- JP-MF-000024143
- Authorised Representative
- Tosoh Europe N.V. BE-AR-000000211
Sources (2)
- EUDAMED adbe9b7e-dad0-4dc1-b7b2-053bf88f6402 61 fields · synced Aug 3, 2026
- EUDAMED 13b728c6-236f-43c2-b048-b4519004be4f 61 fields · synced May 17, 2026