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RESOLVE Hemoglobin Kit
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref FR-9400
by Wallac Oy
Identity
- Trade Name
- RESOLVE Hemoglobin Kit EUDAMEDRESOLVE Systems Neonatal Hemoglobin Kit FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
- Device Name
- RESOLVE Hemoglobin Kit EUDAMEDFor detection of normal and variant hemoglobins. FDA UDI
- Model / Reference
- FR-9400 EUDAMEDFDA UDI
- Description
- For detection of normal and variant hemoglobins. FDA UDI
Identifiers
- Catalog Number
- FR-9400 FDA UDI
- Primary DI / UDI-DI
- 06438147000814 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438147000814 EUDAMED
- 510(k) Number
- K050709 FDA UDI
- FDA Product Code
- GKA FDA UDI
- EMDN Code
- W0103010299 OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER EUDAMED
- GMDN Term
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 864.7415 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
RESOLVE Hemoglobin Kit by Wallac Oy — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06438147000814 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED ccfb2e38-af97-4d3d-86b0-28b10fb4f87f 61 fields · synced May 30, 2026
- FDA UDI 2b0ebc83-3457-4795-aece-be017220fa34 36 fields · synced May 30, 2026