Identity
- Trade Name
- HbA1C Hemolysis, 1 x 1000 ml EUDAMED
- Device Name
- Alkalický promývací roztok EUDAMED
- Model / Reference
- 08-118432 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594214080030 EUDAMED
- Basic UDI-DI
- 859421408SKAIVDP4 EUDAMED
- Direct Marketing DI
- 08594214080030 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Category: Nucleic acid extraction/isolation kit IVD
HbA1C Hemolysis, 1 x 1000 ml by SKALAB s.r.o. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 859421408SKAIVDP4 | Class A | Active |
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Manufacturer
- Manufacturer
- SKALAB s.r.o.
- EUDAMED SRN
- CZ-MF-000029744
Sources (1)
- EUDAMED 230edb50-464f-4bfe-af58-46c20f14839d 61 fields · synced Jun 19, 2026