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RESOLVE Hb Elution Solution
EUDAMEDFDA UDIClass A (EU MDR)
Ref 3024-0010
by Wallac Oy
Identity
- Trade Name
- RESOLVE Hb Elution Solution EUDAMEDRESOLVE Systems Hb Elution Solution FDA UDI
- Generic Name
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
- Device Name
- RESOLVE Hb Elution Solution EUDAMEDFor in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing. FDA UDI
- Model / Reference
- 3024-0010 EUDAMEDFDA UDI
- Description
- For in vitro use with the RESOLVE Hemoglobin Kits for isoelectric focusing. FDA UDI
Identifiers
- Catalog Number
- 3024-0010 FDA UDI
- Primary DI / UDI-DI
- 06438147246120 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438147RESOLVE_HbElutJK EUDAMED
- 510(k) Number
- K050709 FDA UDI
- FDA Product Code
- GKA FDA UDI
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - OTHER EUDAMED
- GMDN Term
- Multiple haemoglobin subtype IVD, kit, electrophoresis FDA UDI
Classification
- Device Class
- Class A 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
New Device
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 Hb Elution Solution by Wallac Oy — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 6438147RESOLVE_HbElutJK | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Wallac Oy
- EUDAMED SRN
- FI-MF-000022620
Sources (2)
- EUDAMED a870c3c1-83f0-4bdc-893e-91c05508cfcd 61 fields · synced Jun 18, 2026
- FDA UDI e4cc329c-ddd2-449f-91c4-41de1fec490c 36 fields · synced May 30, 2026